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Data / Medical devices / United Kingdom / Probo Medical Ltd

Probo Medical Ltd: FDA-registered device maker in Gloucester Gloucestershire, United Kingdom, 22 510(k) clearances

Probo Medical Ltd is registered with the FDA (registration 3010398867) in Gloucester Gloucestershire, United Kingdom. It lists 19 device types. The FDA files 22 510(k) clearances under its listings, the newest dated December 29, 2022. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Probo Medical Ltd
FDA registration number
3010398867
Address
Electron Building Mount Court; Edison Close; Center; The, Gloucester Gloucestershire, United Kingdom, GL2 2FN
Owner or operator
Probo Medical Ltd (10052961)
Roles
Exporter to the US
First device listed
April 23, 2019
Registered through
2026
Brand names listed
Carestream DRX, GE Discovery NM, GE Healthcare, GE Logiq E10, GE Optima 9800, GE Optima CT, GE Rev Evo, GE Senographe Essential and more

Devices it lists

DeviceProduct codeClassRoleSource
Automated Radiological Image Processing SoftwareQIH2Exporter to the USaccessdata.fda.gov
Bronchoscope (Flexible Or Rigid)EOQ2Exporter to the USaccessdata.fda.gov
Catheter, Ultrasound, IntravascularOBJ2Exporter to the USaccessdata.fda.gov
Cystoscope And Accessories, Flexible/RigidFAJ2Exporter to the USaccessdata.fda.gov
Endoscope, Accessories, Narrow Band SpectrumNWB2Exporter to the USaccessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-UrologyFET2Exporter 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
Injector And Syringe, AngiographicDXT2Exporter to the USaccessdata.fda.gov
Interventional Fluoroscopic X-Ray SystemOWB2Exporter 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, Fluoroscopic, Image-IntensifiedJAA2Exporter to the USaccessdata.fda.gov
System, X-Ray, MobileIZL2Exporter to the USaccessdata.fda.gov
System, X-Ray, Tomography, ComputedJAK2Exporter to the USaccessdata.fda.gov
Transducer, Ultrasonic, DiagnosticITX2Exporter 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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 29, 2022K221690OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)FAJSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
September 8, 2021K211597EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound SystemIYNSubstantially EquivalentPhilips Medical Systemsaccessdata.fda.gov
April 17, 2020K200158LOGIQ E10IYNSubstantially EquivalentGE Medical Systems Ultrasound & Primary Care Diagnostics, LLCaccessdata.fda.gov
July 26, 2019K191777Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex editionJAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.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
June 4, 2019K190461Achieva 1.5T, 3.0T and Intera 1.5T MR SystemsLNHSubstantially EquivalentPhilips Medical Systems Nederland B.V.accessdata.fda.gov
March 13, 2018K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertIYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
June 1, 2017K170904Biograph Horizon PET/CTKPSSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
November 15, 2013K132951MAGNETOM AERALNHSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
August 30, 2013K131576OPTIMA CT660JAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
January 10, 2013K121959EVIS EXERA III VIDEO SYSTEMEOQSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
April 13, 2012K120062DRX-REVOLUTION MOBILE X-RAY SYSTEMIZLSubstantially EquivalentCarestream Health, Inc.accessdata.fda.gov
April 10, 2012K113466AQUILION ONEJAKSubstantially EquivalentToshiba Medical Systems Coporation, Japanaccessdata.fda.gov
December 22, 2011K110798SENOGRAPHE DS, SENOGRAPHE ESSENTIALMUESubstantially EquivalentGeneral Electric Companyaccessdata.fda.gov
June 3, 2011K111445DISCOVERY NM 630KPSSubstantially EquivalentGE Healthcareaccessdata.fda.gov
January 13, 2009K083155HD CAMERA HEAD OTV-S7PROH-HD-L08EFETSubstantially EquivalentOlympus Medical Systems Corporationaccessdata.fda.gov
October 8, 2008K082761GE LIGHTSPEED 7.2 CT SCANNER SYSTEMJAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
May 14, 2008K080701SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTIONIZLSubstantially EquivalentShimadzu Corp.accessdata.fda.gov
October 4, 2005K052164MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006ALNHSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 1, 2005K050297SOMATOM EMOTION 16JAKSubstantially EquivalentSiemens Medical Solution, Inc. USAaccessdata.fda.gov
April 17, 2002K021049OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEMOWBSubstantially EquivalentGe Oec Medical Systemsaccessdata.fda.gov
September 25, 1995K935668MEDRAD SPECTRIS MR INJECTORDXTSubstantially EquivalentMedrad, Inc.accessdata.fda.gov

Compare with other makers

Updated December 29, 2022. 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.