Probo Medical Ltd

FDA Device Registration & Listing · Gloucester Gloucestershire, GB · Registration 3010398867

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
3010398867
FEI Number
3010398867
Entity Name
Probo Medical Ltd
City/State/Country
Gloucester Gloucestershire, GB
Establishment Address
Electron Building, Mount Court; Edison Close; Center; The, Gloucester Gloucestershire GL2 2FN, GB
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Probo Medical Ltd (Owner Number: 10052961)
Owner / Operator Contact Address
Mount Court, Waterwells Business Park, Gloucester, GB-GLS GL2 2FN, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K110798
PMA Number
N/A

All Registered Proprietary Names

Philips Achieva MRI GE Logiq E10 Shimadzu MobileDART MAGNETOM AERA Olympus Processor Siemens Somatom Emotion Philips Epiq GE Optima CT GE Senographe Essential

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2026-04-27
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-04-27
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-06-01
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-06-01
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-06-01
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2026-03-05
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2026-03-03
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2026-05-20
NWB Endoscope, Accessories, Narrow Band Spectrum Gastroenterology, Urology Class 2 876.1500 2026-05-20
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-03-11
OBJ Catheter, Ultrasound, Intravascular Cardiovascular Class 2 870.1200 2026-03-24
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2026-03-24
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2026-03-24
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2026-03-24
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2026-03-24
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2019-11-07
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2026-06-09

Official Correspondent

Zack Walker

US Agent Details

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

Related Public Records

Same Entity

Probo Medical Ltd
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
K033504 General Electric Co. GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM 2003-11-25
K013636 GE Medical Systems SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY 2002-01-24
K250443 Siemens Healthcare GmbH MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile 2025-06-16
K151015 Hitachi Medical Systems America, Inc. ECHELON Oval V 5.0 MRI System 2015-07-29
K910715 Philips Medical Systems (Cleveland), Inc. VISTA HPQ SYSTEM 1991-06-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0029-2007 Hitachi Medical Systems America Inc 2
MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014 Philips Medical Systems (Cleveland) Inc 2
Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Z-0389-2024 Philips North America Llc 2
Achieva 1.5T
Z-0390-2024 Philips North America Llc 2
Achieva 1.5T Conversion
Z-0391-2024 Philips North America Llc 2
Achieva 1.5T Initial System

Similar Registrations

Registration Number Establishment Name Location
3012169560 SIARON MEDICAL LTD Vancouver British Columbia, CA
3004754211 SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. SHENZHEN Guangdong, CN
3015329423 GE Healthcare Manufacturing LLC Florence, SC, US
3042177665 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. BEST Noord-Brabant, NL
3008284470 GE Healthcare (China) Co., Ltd. Beijing, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010398867. Last updated year: 2026. Please use registration number 3010398867 when referencing this establishment in official correspondence.
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