ClearanceBrief
Panels › Radiology › Product code OUO · Class 2

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Regulation 892.1200

2510(k)s in 12 months (15 all time)
0recalls in 12 months (9 all time)
9recalls that name a 510(k)
Get daily alerts for OUOSample briefCSV

Top companies in OUO

Company510(k)sRecalls
Siemens Medical Solutions USA, Inc.51
GE Healthcare04
Ge Medical Systems, LLC31
Shanghai United Imaging Healthcare Co., Ltd.40
Philips Medical Systems (Cleveland) Inc03
Cubresa, Inc.10
Philips Healthcare (Cleveland)10
Siemens Healthineers AG10
DateFirm and productCodeLinked 510(k)
Sep 30, 2025Siemens Medical Solutions USA, Inc
Biograph mMR. Model Number: 10433372.
Open, Classified		 OUOK200213
Aug 2, 2024GE Medical Systems, LLC
SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance
Open, Classified		 OUOK142098
K163619 +1
Dec 23, 2021GE Healthcare, LLC
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA PET/MR System, tomographic imager combining emission computed tomography with nuclear magnetic resonance system.
Open, Classified		 OUOK142098
K163619
Jul 12, 2021GE Healthcare, LLC
SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Open, Classified		 OUOK163619
Sep 8, 2020GE Healthcare, LLC
Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance - Product Usage: The combined system maintains independent functionality of the MR and PET devices, allowing f
Terminated		 OUOK163619
Nov 10, 2015GE Healthcare
GE Healthcare, SIGNA PET/MR 3.0T. Product Usage: The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registrati
Terminated		 OUOK142098
Aug 31, 2015Philips Medical Systems (Cleveland) Inc
Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems
Terminated		 OUOK103483
Jun 11, 2015Philips Medical Systems (Cleveland) Inc
Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Terminated		 OUOK103483
May 22, 2012Philips Medical Systems (Cleveland) Inc
Ingenuity TF PET/MRI System v.3.7.1, 510(k) #K103483, Model #882380. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic R
Terminated		 OUOK103483

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.