PROBO MEDICAL SAS

FDA Device Registration & Listing · NANTES Loire-Atlantique, FR · Registration 3035950510

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3035950510
FEI Number
3035950510
Entity Name
PROBO MEDICAL SAS
City/State/Country
NANTES Loire-Atlantique, FR
Establishment Address
1 Rue Louis Breguet, NANTES Loire-Atlantique 44980, FR
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
PROBO Medical SAS (Owner Number: 10086551)
Owner / Operator Contact Address
1 Rue Louis Breguet, NANTES, FR-44 44980, FR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K251169
PMA Number
N/A

All Registered Proprietary Names

Ultrasound Processor- EU-ME2 with accessories Keyboard and Pigtail Hologic Selenia Dimensions Mammograph Siemens Symbia T2 Slice Spect Siemens Biograph Horizon 16 GE Lightspeed 7 VCT Philips Medical Breast Coil Philips X7-2t GE Healthcare System, X-Ray, Tomography, Computed Multi Purpose Flex M Coil Philips Coils System, X-Ray, Tomography, Computed Philips Medical Probe System Xray Siemens Artis Zee Philips Probe GE Healthcare Probe

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-01-12
ODG Endoscopic Ultrasound System, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2026-01-12
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-01-12
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-01-12
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2026-03-05
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-02-10
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2026-02-10
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2026-04-10
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-10
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-04-10
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2026-05-07
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2026-02-04
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-02-04
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-02-04
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-02-04
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2025-12-10
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2025-12-10
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2025-12-10
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-01-14
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2026-02-04
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2026-02-25
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-01-14
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2022-12-07
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2022-12-07
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2022-12-07
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-01-14
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-05-22
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-05-22
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-05-22
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2026-05-22
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-04-21
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-04-21
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2026-04-21
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2026-04-21
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-04-21
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-05-21
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-05-21
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-05-21

Official Correspondent

Julien Boutter

US Agent Details

Jehovany Hernandez Business: Probo Medical Inc Email: jhernandez@probomedical.com Phone: (931) 4364550

Related Public Records

Same Entity

PROBO Medical SAS
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K951723 GE Medical Systems GE B510 TRANSDUCER 1995-11-14
K903562 Diasonics, Inc. CW DOPPLER 2.25 MHZ PROBE 1992-03-02
K945318 Tetra Corp. TETRAD MODEL 6F, END-VIEWING, ENDOCAVITY PROBE, 4.5/8.5 MHZ, CA 1995-05-05
K231666 FUJIFILM Healthcare Americas Corporation Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) 2023-12-13
K191007 Supersonic Imagine Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems 2019-10-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0009-2022 DJO, LLC 2
GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND
Z-0010-2022 DJO, LLC 2
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FRANCE kits:
Z-0029-2022 Aesthetics Systems Usa Inc 2
Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Z-0038-2026 ImaCor Inc. 2
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Z-0189-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035950510. Last updated year: 2026. Please use registration number 3035950510 when referencing this establishment in official correspondence.
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