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Data / Medical devices / France / Probo Medical SAS

Probo Medical SAS: FDA-registered device maker in NANTES Loire-Atlantique, France, 36 510(k) clearances and 1 PMA approval

Probo Medical SAS is registered with the FDA (registration 3035950510) in NANTES Loire-Atlantique, France. It lists 19 device types. The FDA files 36 510(k) clearances and 1 PMA approval under its listings, the newest dated January 14, 2026. Registered through 2027. 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 SAS
FDA registration number
3035950510
Address
1 Rue Louis Breguet, NANTES Loire-Atlantique, France, 44980
Owner or operator
PROBO Medical SAS (10086551)
Roles
Exporter to the US
First device listed
December 7, 2022
Registered through
2027
Brand names listed
Aloka Arieta 850, Aloka F75, Aquilion One Genesis, Breast Coil, GE Discovery IGS, GE Discovery MI, GE Discovery NM/CT 670, GE Healthcare 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
Coil, Magnetic Resonance, SpecialtyMOS2Exporter to the USaccessdata.fda.gov
Endoscope, Accessories, Narrow Band SpectrumNWB2Exporter to the USaccessdata.fda.gov
Endoscopic Ultrasound System, Gastroenterology-UrologyODG2Exporter 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
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, AngiographicIZI2Exporter to the USaccessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-IntensifiedJAA2Exporter to the USaccessdata.fda.gov
System, X-Ray, StationaryKPR2Exporter 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
January 14, 2026K254190dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0TMOSSubstantially EquivalentPhilips Medical Systems Nederland B.V.accessdata.fda.gov
August 1, 2025K250941Revolution VibeJAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
July 31, 2025K250738YSIO X.preeKPRSubstantially EquivalentSiemens Medical Solutionsaccessdata.fda.gov
July 10, 2025K251169Vivid PioneerIYNSubstantially EquivalentGE Medical Systems Ultrasound and Primary Care Diagnosticsaccessdata.fda.gov
July 3, 2025K250822SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.PulseJAKSubstantially 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 14, 2022K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast CoilMOSSubstantially EquivalentNeocoil, LLCaccessdata.fda.gov
August 23, 2022K2222571.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee CoilMOSSubstantially EquivalentInvivo Corporation (Business Trade Name: Philips)accessdata.fda.gov
March 5, 2021K203346OEC 3DOXOSubstantially EquivalentGe Oec Medical Systems, Inc.accessdata.fda.gov
November 9, 2020K203128EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUSIYNSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
October 24, 2019K192686Revolution Maxima, Revolution AceJAKSubstantially EquivalentGe Hangwei Medical Systems Co., Ltd.accessdata.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
February 14, 2019K183221MAGNETOM Amira, MAGNETOM SempraLNHSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
August 15, 2018K181407Artis zee/zeego & Artis Q/Q.zenOWBSubstantially EquivalentSiemens Medical Solution USA, Inc.accessdata.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
April 13, 2018K173632SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GOJAKSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 13, 2018K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertIYNSubstantially EquivalentGE Healthcareaccessdata.fda.gov
March 8, 2018K173713HS70A Diagnostic Ultrasound SystemIYNSubstantially EquivalentSamsung Medison Co., Ltd.accessdata.fda.gov
February 28, 2018K173739ALOKA ARIETTA 850IYNSubstantially EquivalentHitachi Healthcare Americas Corporationaccessdata.fda.gov
October 6, 2017K172188Aquilion Prime SP, TSX-303B/1, v8.4JAKSubstantially EquivalentToshiba Medical Systems Coroporationaccessdata.fda.gov
June 1, 2017K170904Biograph Horizon PET/CTKPSSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
August 11, 2016K161574Discovery MIKPSSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
June 9, 2016K160587Aquilion ONE (TSX-305A/3) V7.3JAKSubstantially EquivalentToshibamedical Systems Corporationaccessdata.fda.gov
May 21, 2013K130842ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIESIZISubstantially EquivalentPhilips Medical Systems Nederland B.V.accessdata.fda.gov
January 18, 2013K123828PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially EquivalentHitachi Aloka Medical, Ltd.accessdata.fda.gov
January 10, 2013K121959EVIS EXERA III VIDEO SYSTEMEOQSubstantially EquivalentOlympus Medical Systems Corp.accessdata.fda.gov
December 13, 2012K123492DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)MOSSubstantially EquivalentPhilips Medical Systemsaccessdata.fda.gov
June 12, 2012K120833DISCOVERY CT750 HDJAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
February 14, 2012K113403GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEMOWBSubstantially EquivalentGE Medical Systems SCSaccessdata.fda.gov
January 26, 2012K110066AQUILION PRIMEJAKSubstantially EquivalentToshiba America Medical Systems, In.Caccessdata.fda.gov
June 24, 2011K111513CX50 DIAGNOSTIC ULTRASOUND SYSTEMIYNSubstantially EquivalentPhilips Ultrasound, Inc.accessdata.fda.gov
December 10, 2009K093514DISCOVERY MODEL NM/CT 670KPSSubstantially EquivalentGe Medical Systems F.I. Haifaaccessdata.fda.gov
October 8, 2008K082816GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEMJAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov
May 17, 2004K041166SIEMENS ENHANCED IMAGING SYSTEMKPSSubstantially EquivalentSiemens Medical Solutions USA, Inc.accessdata.fda.gov
March 1, 2004K040372LIGHTSPEED 7.0 CT SCANNER SYSTEMJAKSubstantially EquivalentGe Medical Systems, LLCaccessdata.fda.gov

PMA approvals

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

ApprovedPMA numberDeviceProduct codeSupplementsLatest decisionSource
March 15, 2002P010025LORAD DIGITAL BREAST IMAGERMUE17November 16, 2010accessdata.fda.gov

Compare with other makers

Updated January 14, 2026. 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.