FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
3361–3384 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 04, 2018
CURA 16
K173076 · JAK
Fmi Medical Systems, Inc.
Radiology · 370d
Cleared Oct 03, 2018
2MP Color LCD Monitor CL-R211
K182539 · PGY
Jvckenwood Corporation
Radiology · 19d
Cleared Oct 03, 2018
Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation...
K182050 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 64d
Cleared Oct 03, 2018
BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes,...
K181903 · JAQ
Varian Medical Systems, Inc.
Radiology · 79d
Cleared Oct 03, 2018
uMR 790
K181371 · LNH
Shanghai United Imaging Healthcare...
Radiology · 133d
Cleared Oct 03, 2018
uMR 780
K181370 · LNH
Shanghai United Imaging Healthcare...
Radiology · 133d
Cleared Sep 28, 2018
Alphenix, INFX-8000F/B, V8.0
K182415 · OWB
Canon Medical Systems Corporation
Radiology · 24d
Cleared Sep 28, 2018
E-CUBE 12
K181277 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 137d
Cleared Sep 25, 2018
IBM iConnect Access
K182290 · LLZ
Merge Healthcare Incorporated
Radiology · 33d
Cleared Sep 25, 2018
Synapse 3D Optional Tools
K181773 · LLZ
Fujifilm Corporation
Radiology · 84d
Cleared Sep 24, 2018
AMADEO M-DR mini, AMADEO M-AX mini
K182317 · IZL
Oehm Und Rehbein GmbH
Radiology · 28d
Cleared Sep 24, 2018
iNtuition-T1 Mapping and T2/T2* Mapping
K180916 · LLZ
Terarecon,Inc.
Radiology · 168d
Cleared Sep 21, 2018
Volpara Imaging Software
K182310 · LLZ
Volpara Health Technologies Limited
Radiology · 28d
Cleared Sep 21, 2018
InVivo Web Viewer
K181926 · LLZ
Anatomage, Inc.
Radiology · 65d
Cleared Sep 21, 2018
VeriSuite
K181789 · LHN
Medcom GmbH
Radiology · 78d
Cleared Sep 21, 2018
OpenSight
K172418 · LLZ
Novarad Corporation
Radiology · 407d
Cleared Sep 20, 2018
LOGIQ P9
K181783 · IYN
Ge Healthcare
Radiology · 79d
Cleared Sep 14, 2018
Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A
K182223 · JAK
Canon Medical Systems, USA
Radiology · 29d
Cleared Sep 14, 2018
QT Ultrasound Breast Scanner - 1
K182213 · IYO
Qt Ultrasound, LLC
Radiology · 30d
Cleared Sep 14, 2018
MX40 Mobile Digital X-ray System
K181874 · IZL
Huestis Machine Corporation
Radiology · 63d
Cleared Sep 14, 2018
DORADOnova MR3T
K173926 · IYE
Lap GmbH Laser Applikationen
Radiology · 262d
Cleared Sep 13, 2018
RiX70 DC
K182206 · EHD
Trident S.R.L
Radiology · 29d
Cleared Sep 13, 2018
Planmeca Viso
K181576 · OAS
Planmeca Oy
Radiology · 90d
Cleared Sep 10, 2018
XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0
K181415 · OWB
Canon Medical Systems Corporation
Radiology · 103d