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Data / Medical devices / Denmark / LBN Medical A/S

LBN Medical A/S: FDA-registered device maker in Aalborg Nordjylland, Denmark, 121 510(k) clearances and 2 PMA approvals

LBN Medical A/S is registered with the FDA (registration 3009196578) in Aalborg Nordjylland, Denmark. It lists 24 device types. The FDA files 121 510(k) clearances and 2 PMA approvals under its listings, the newest dated November 24, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
3009196578
Address
Gugvej 70, Aalborg Nordjylland, Denmark, 9210
Owner or operator
LBN Medical ApS (10055731)
Roles
Exporter to the US
First device listed
September 27, 2017
Registered through
2027
Brand names listed
Acuson Probe 9L4 S2000/SC2000, Acuson Probe EC9-4 vaginal, Acuson Probe EV8C4, Acuson Probe V5M, Acuson TEE Probe V7M, Acuson probe 4V1C, Aquilion Prime, Arcadis Varic and more

Devices it lists

DeviceProduct codeClassRoleSource
Abutment, Implant, Dental, EndosseousNHA2Exporter to the USaccessdata.fda.gov
Automated Radiological Image Processing SoftwareQIH2Exporter to the USaccessdata.fda.gov
Biopsy NeedleFCG2Exporter to the USaccessdata.fda.gov
Biopsy Needle Guide KitOIJ2Exporter to the USaccessdata.fda.gov
Catheter, Ultrasound, IntravascularOBJ2Exporter to the USaccessdata.fda.gov
Coil, Magnetic Resonance, SpecialtyMOS2Exporter to the USaccessdata.fda.gov
Digital Breast TomosynthesisOTE3Exporter to the USaccessdata.fda.gov
Full Field Digital, System, X-Ray, MammographicMUE2Exporter to the USaccessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, MobileOXO2Exporter to the USaccessdata.fda.gov
Implant, Endosseous, Root-FormDZE2Exporter to the USaccessdata.fda.gov
Injector And Syringe, AngiographicDXT2Exporter to the USaccessdata.fda.gov
Interventional Fluoroscopic X-Ray SystemOWB2Exporter to the USaccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Exporter to the USaccessdata.fda.gov
System, Imaging, Pulsed Doppler, UltrasonicIYN2Exporter to the USaccessdata.fda.gov
System, Imaging, Pulsed Echo, UltrasonicIYO2Exporter to the USaccessdata.fda.gov
System, Nuclear Magnetic Resonance ImagingLNH2Exporter to the USaccessdata.fda.gov
System, Nuclear Magnetic Resonance SpectroscopicLNI2Exporter to the USaccessdata.fda.gov
System, Tomography, Computed, EmissionKPS2Exporter to the USaccessdata.fda.gov
System, X-Ray, Extraoral Source, DigitalMUH2Exporter to the USaccessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-IntensifiedJAA2Exporter to the USaccessdata.fda.gov
System, X-Ray, MammographicIZH2Exporter to the USaccessdata.fda.gov
System, X-Ray, Tomography, ComputedJAK2Exporter to the USaccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Exporter to the USaccessdata.fda.gov
X-Ray, Tomography, Computed, DentalOAS2Exporter to the USaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 121.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 24, 2025K252328Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
January 15, 2025K243328Ziehm Vision RFDOWBSubstantially EquivalentZiehm Imaging GmbHaccessdata.fda.gov
December 20, 2024K242168Voluson Expert 18; Voluson Expert 20; Voluson Expert 22IYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
November 19, 2024K242523ACUSON Sequoia Diagnostic Ultrasound System; ACUSON Sequoia Select Diagnostic Ultrasound System; ACUSON Origin Diagnostic Ultrasound System; ACUSON Origin ICE Diagnostic Ultrasound SystemIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
November 15, 2024K243299ACUSON Redwood Diagnostic Ultrasound SystemIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 26, 2024K233650SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceedJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
February 13, 2024K233788EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYNSubstantially EquivalentPhilips Ultrasound, LLCaccessdata.fda.gov
October 30, 2023K232145ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound SystemIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
October 23, 2023K231560MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fitLNHSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
October 3, 2023K231772V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound SystemIYNSubstantially EquivalentSamsung Medison Co., Ltd.accessdata.fda.gov
February 13, 2023K230207ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound SystemIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
February 6, 2023K223735ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound SystemIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
June 14, 2022K221500ACUSON Sequoia Diagnostic Ultrasound SystemIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
June 6, 2022K220358Voluson Expert 22, Voluson Expert 20, Voluson Expert 18IYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
February 4, 2022K212419Magnifico Open, Magnifico MSKLNHSubstantially EquivalentEsaote, S.p.A.accessdata.fda.gov
September 9, 2021K211824HERA W9, HERA W10 Diagnostic Ultrasound SystemIYNSubstantially EquivalentSamsung Medison Co., Ltd.accessdata.fda.gov
August 27, 2021K211524LOGIQ E10s, LOGIQ FortisIYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
April 1, 2021K210743ACUSON Redwood Diagnostic Ultrasound SystemIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 10, 2021K210164Vantage Elan 1.5T, MRT-2020, V6.0LNHSubstantially EquivalentCanon Medical Systems Corporationaccessdata.fda.gov
January 8, 2021K203114LOGIQ P10, LOGIQ P9, LOGIQ P8IYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
November 13, 2020K202132VenueIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
October 15, 2020K202683ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound SystemIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
October 11, 2020K201828Voluson SWIFT, Voluson SWIFT+IYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
October 8, 2020K201972Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1IYNSubstantially EquivalentCanon Medical Systems Corporationaccessdata.fda.gov
June 24, 2020K201462ACUSON Sequoia Diagnostic Ultrasound SystemIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
May 7, 2020K200699HS70A Diagnostic Ultrasound SystemIYNSubstantially EquivalentSamsung Medison Co., Ltd.accessdata.fda.gov
May 1, 2020K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound SystemIYNSubstantially EquivalentPhilips Ultrasound, Inc.accessdata.fda.gov
April 17, 2020K200158LOGIQ E10IYNSubstantially EquivalentGE Medical Systems Ultrasound & Primary Care Diagnostics, LLCaccessdata.fda.gov
April 1, 2020K200119LOGIQ E10sIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
March 6, 2020K200304EPIQ Diagnostic Ultrasound SystemIYNSubstantially EquivalentPhilips Ultrasound, Inc.accessdata.fda.gov
February 14, 2020K193248Biograph Vision, Biograph mCT Family of PET/CTsKPSSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
January 31, 2020K193257ACUSON Sequoia Diagnostic Ultrasound SystemIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
October 25, 2019K191007Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic SystemsIYNSubstantially EquivalentSupersonic Imagineaccessdata.fda.gov
September 18, 2019K191663Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0IYNSubstantially EquivalentCanon Medical Systems Corporationaccessdata.fda.gov
August 9, 2019K191233ARIETTA 750IYNSubstantially EquivalentHitachi Healthcare Americasaccessdata.fda.gov
July 26, 2019K191777Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex editionJAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
July 19, 2019K191467Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0IYNSubstantially EquivalentCanon Medical Systems Corporationaccessdata.fda.gov
June 27, 2019K190578SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM ConfidenceJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
January 28, 2019K183362Venue GOIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
January 22, 2019K182894HM70A Diagnostic Ultrasound SystemIYNSubstantially EquivalentSamsung Medison Co., Ltd.accessdata.fda.gov
November 21, 2018K182277Versana PremierIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
November 9, 2018K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemIYNSubstantially EquivalentPhilips Ultrasound, Inc.accessdata.fda.gov
November 2, 2018K182427Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound SystemIYNSubstantially EquivalentCanon Medical Systems Corporationaccessdata.fda.gov
October 31, 2018K182679Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1IYNSubstantially EquivalentCanon Medical Systems Corporationaccessdata.fda.gov
October 19, 2018K182450Vivid S60N, Vivid S70NIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
July 27, 2018K181485EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound SystemIYNSubstantially EquivalentPhilips Ultrasound, Inc.accessdata.fda.gov
May 11, 2018K180409HS40 Diagnostic Ultrasound SystemIYNSubstantially EquivalentSamsung Medison Co., Ltd.accessdata.fda.gov
May 2, 2018K180599VenueIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
December 19, 2017K171012Veraview X800OASSubstantially EquivalentJ. Morita USA, Inc.accessdata.fda.gov
November 2, 2017K173341Vivid E80, Vivid E90, Vivid E95IYNSubstantially EquivalentGE Medical Systemsaccessdata.fda.gov
October 6, 2017K172188Aquilion Prime SP, TSX-303B/1, v8.4JAKSubstantially EquivalentToshiba Medical Systems Coroporationaccessdata.fda.gov
October 4, 2017K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemIYNSubstantially EquivalentPhilips Health Careaccessdata.fda.gov
June 30, 2017K170177Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1JAKSubstantially EquivalentToshibamedical Systems Corporationaccessdata.fda.gov
June 21, 2017K170714VenueIYNSubstantially EquivalentGE Medical Systems Ultrasound & Primary Care Diagnostics, LLCaccessdata.fda.gov
June 12, 2017K170823Vivid E80, Vivid E90, Vivid E95IYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
May 30, 2017K163702Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1IYNSubstantially EquivalentToshibamedical Systems Corporationaccessdata.fda.gov
April 11, 2017K170445LOGIQ S8IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
January 10, 2017K163120EPIQ 5 Diagnostic Ultrasound System; EPIQ 7 Diagnostic Ultrasound System; Affiniti 50 Diagnostic Ultrasound System; Affiniti 70 Diagnostic Ultrasound SystemIYNSubstantially EquivalentPhilips Ultrasound, Inc.accessdata.fda.gov
January 4, 2017K163396ACUSON P500 Ultrasound SystemIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
October 3, 2016K162269Voluson E6, Voluson E8, Voluson E10IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
September 21, 2016K161843Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0IYNSubstantially EquivalentToshibamedical Systems Corporationaccessdata.fda.gov
September 14, 2016K162329CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound SystemIYNSubstantially EquivalentPhilips Health Careaccessdata.fda.gov
August 5, 2016K161706Vivid iqIYNSubstantially EquivalentGe Medical Systems Ultrasound and Primary Care Diagnostics Laccessdata.fda.gov
June 9, 2016K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5TLNHSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
April 6, 2016K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemIYNSubstantially EquivalentPhilips Ultrasound, Inc.accessdata.fda.gov
April 1, 2016K153486Affirm Prone Biopsy SystemIZHSubstantially EquivalentHologic, Inc.accessdata.fda.gov
February 26, 2016K160182LOGIQ S7 ExpertIYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
February 25, 2016K160184Voluson S6, Voluson S8, Voluson S10IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
November 18, 2015K152758Venue 50IYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
October 6, 2015K152369ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond SystemIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc. Ultrasound Groupaccessdata.fda.gov
September 29, 2015K152195LOGIQ S8IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
July 9, 2015K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0IYNSubstantially EquivalentToshibamedical Systems Corporationaccessdata.fda.gov
June 18, 2015K151028LOGIQ eIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
May 9, 2015K150533Terason uSmart3200T Ultrasound SystemIYNSubstantially EquivalentTeratech Corp.accessdata.fda.gov
March 4, 2015K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging SystemIYNSubstantially EquivalentGe Vingmed Ultrasound ASaccessdata.fda.gov
February 10, 2015K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsIYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
October 28, 2014K141459APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0IYNSubstantially EquivalentToshibamedical Systems Corporationaccessdata.fda.gov
October 23, 2014K142876ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound SystemsIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
October 10, 2014K142628Acuson SC2000 Diagnostic Ultrasound SystemIYNSubstantially EquivalentSiemens Medi Cal Solutions, Inc.accessdata.fda.gov
October 10, 2014K142323Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound SystemIYNSubstantially EquivalentGe Medical Systems Israel , Ltd.accessdata.fda.gov
August 7, 2014K141846ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEMIYNSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
June 11, 2014K140854INTRA-OPERATIVE ULTRASOUND TRANSDUCERITXSubstantially EquivalentHitachi Aloka Medical, Ltd.accessdata.fda.gov
May 15, 2014K1410936VT-D ULTRASOUND TRANSDUCERITXSubstantially EquivalentGe Vingmed Ultrasound ASaccessdata.fda.gov
March 21, 2014K133657DISCOVERY PET/CT 710KPSSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
January 17, 2014K132410DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 WJAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
January 10, 2014K132335ULTRASOUND SCANNER FLEX FOCUS 1202IYNSubstantially EquivalentB-K Medical Apsaccessdata.fda.gov
December 24, 2013K133431VENUE 50IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
December 16, 2013K133454SONOSITE EDGE ULTRASOUND SYSTEMIYNSubstantially EquivalentFUJIFILM Sonosite, Inc.accessdata.fda.gov
September 26, 2013K132654ACUSON SC2000 DIAGNOSTIC ULTRASOUND SYSTEMIYOSubstantially EquivalentSiemens Medical Solutions USA, Inc. Ultrasound Groaccessdata.fda.gov
September 24, 2013K131937VOLUSON I/EIYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
August 30, 2013K131576OPTIMA CT660JAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
August 26, 2013K131527LOGIQ S8IYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
August 21, 2013K132304EPIQ DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially EquivalentPhilips Ultrasound, Inc.accessdata.fda.gov
March 25, 2013K130173SONOSITE MAXX SERIES ULTRASOUND SYSTEMIYNSubstantially EquivalentFUJIFILM Sonosite, Inc.accessdata.fda.gov
January 29, 2013K123873CONTRAST ENHANCED DIGITAL MAMMOGRAPHYMUESubstantially EquivalentHologic, Inc.accessdata.fda.gov
December 21, 2012K123754CX50 3.0 DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially EquivalentPhilips Ultrasound, Inc.accessdata.fda.gov
September 20, 2012K1216761.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANTLNHSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
August 16, 2012K122234OEC 9900 ELITEOWBSubstantially EquivalentGe Healthcare Surgery GE Oec Medical Systems, Inc.accessdata.fda.gov
July 5, 2012K120530DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION SDZESubstantially EquivalentDentin Implants Technologies , Ltd.accessdata.fda.gov
October 4, 2011K111551OEC(R) 9800, OEC(R) 9800 PLUSOWBSubstantially EquivalentGe Oec Medical Systems, Inc.accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
February 11, 2011P080003SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMOTE10November 24, 2025accessdata.fda.gov
March 15, 2002P010025LORAD DIGITAL BREAST IMAGERMUE17November 16, 2010accessdata.fda.gov

Compare with other makers

Updated November 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.