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
3145–3168 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 12, 2019
Deep Learning Image Reconstruction
K183202 · JAK
Ge Medical Systems, LLC
Radiology · 144d
Cleared Apr 12, 2019
3T 32 Channel Head Coil
K182737 · MOS
Nova Medical, Inc.
Radiology · 196d
Cleared Apr 12, 2019
InstaRISPACS / InstaZFP / InstaMobi v5.0
K182572 · LLZ
Meddiff Technologies Pvt. , Ltd.
Radiology · 206d
Cleared Apr 11, 2019
Eye Prime
K190786 · IYO
Ellex Medical Pty, Ltd.
Radiology · 15d
Cleared Apr 09, 2019
DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System
K183660 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 103d
Cleared Apr 08, 2019
VIVIX-S 1751S
K190611 · MQB
Vieworks Co., Ltd.
Radiology · 28d
Cleared Apr 08, 2019
Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)
K183606 · IYE
Scandidos AB
Radiology · 103d
Cleared Apr 08, 2019
JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD...
K183496 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 112d
Cleared Apr 08, 2019
Bone VCAR (BVCAR)
K183204 · JAK
GE Medical Systems SCS
Radiology · 140d
Cleared Apr 05, 2019
R190/R191 LCD Monitor
K183494 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 109d
Cleared Apr 05, 2019
TCD-X
K182175 · IYN
Atys
Radiology · 238d
Cleared Apr 04, 2019
Pixx2430 Digital Diagnostic X-Ray Receptor Panel
K190691 · MQB
Pixxgen Corporation
Radiology · 17d
Cleared Apr 04, 2019
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System
K183377 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 119d
Cleared Apr 02, 2019
ARIETTA 50
K190248 · IYN
Hitachi Healthcare Americas
Radiology · 54d
Cleared Apr 01, 2019
DBSWIN and VISTAEASY Imaging Software
K190629 · LLZ
Durr Dental SE
Radiology · 20d
Cleared Apr 01, 2019
7400 Ultrasound Systems
K190447 · IYN
Navigant Consulting - on Behalf of...
Radiology · 35d
Cleared Mar 29, 2019
Monaco RTP System
K190178 · MUJ
Elekta, Inc.
Radiology · 56d
Cleared Mar 29, 2019
Thoracic VCAR with GSI Pulmonary Perfusion
K183210 · LLZ
GE Medical Systems SCS
Radiology · 130d
Cleared Mar 29, 2019
CS-series-FP with Optional ROI Accessory CA-100S
K182834 · JAA
Omega Medical Imaging, LLC
Radiology · 171d
Cleared Mar 28, 2019
Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic...
K190186 · IYO
Edan Instruments, Inc.
Radiology · 55d
Cleared Mar 27, 2019
Mimics Medical
K183105 · LLZ
Materialise NV
Radiology · 139d
Cleared Mar 26, 2019
Synapse PACS
K190232 · LLZ
Fujifilm Corporation
Radiology · 48d
Cleared Mar 25, 2019
InTouch Thermal Camera
K181716 · LHQ
Intouch Technologies, Inc., D.B.A....
Radiology · 270d
Cleared Mar 22, 2019
uWS-MR
K183164 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 127d