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
3865–3888 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 30, 2017
Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1
K170177 · JAK
Toshibamedical Systems Corporation
Radiology · 162d
Cleared Jun 30, 2017
Dynamic Visualization II Image Processing Option for the FDX Console...
K163624 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 190d
Cleared Jun 27, 2017
RayStation
K171536 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 33d
Cleared Jun 27, 2017
Halcyon
K170817 · IYE
Varian Medical Systems, Inc.
Radiology · 99d
Cleared Jun 23, 2017
SUITESTENSA
K163668 · LLZ
Ebit Srl
Radiology · 178d
Cleared Jun 22, 2017
CUBEScan™ BioCon-900 (Bladder Volume Measurement System)
K171591 · IYO
Mcube Technology Co., Ltd.
Radiology · 22d
Cleared Jun 21, 2017
BSD4343R Digital Flat Panel X-ray Detector
K171485 · MQB
Bontech, Inc.
Radiology · 30d
Cleared Jun 21, 2017
DRX-Revolution Nano Mobile X-ray System
K170755 · IZL
Carestream Health, Inc.
Radiology · 100d
Cleared Jun 21, 2017
Venue
K170714 · IYN
GE Medical Systems Ultrasound &...
Radiology · 104d
Cleared Jun 16, 2017
Infinix INFX-8000V, V6.40
K170909 · OWB
Toshiba Medical Systems Coroporation
Radiology · 80d
Cleared Jun 16, 2017
Green16/Green18 (Model: PHT-65LHS)
K170066 · OAS
VATECH Co., Ltd.
Radiology · 158d
Cleared Jun 14, 2017
Vivid S60N, Vivid S70N
K170878 · IYN
GE Medical Systems Ultrasound &...
Radiology · 82d
Cleared Jun 14, 2017
EchoPAC Software Only, EchoPAC Plug-in
K170847 · LLZ
GE Medical Systems Ultrasound and...
Radiology · 86d
Cleared Jun 14, 2017
MAGNETOM Vida
K170396 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 125d
Cleared Jun 14, 2017
BodyTom Elite
K170238 · JAK
Neurologica Corporation, A Subsidiary...
Radiology · 139d
Cleared Jun 12, 2017
SonoSite X-Porte Ultrasound System
K171437 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 27d
Cleared Jun 12, 2017
1417WCC_127um and1417WCC_140um
K171418 · MQB
Rayence Co., Ltd.
Radiology · 28d
Cleared Jun 12, 2017
1417WGC_127um and 1417WGC_140um
K171417 · MQB
Rayence Co., Ltd.
Radiology · 28d
Cleared Jun 12, 2017
Vivid E80, Vivid E90, Vivid E95
K170823 · IYN
GE Medical Systems Ultrasound and...
Radiology · 84d
Cleared Jun 12, 2017
MELODY, Remote Control System for Ultrasound Probe
K161354 · IYO
Adecho Tech
Radiology · 392d
Cleared Jun 09, 2017
1717SCC_127um and 1717SCC_140um
K171420 · MQB
Rayence Co., Ltd.
Radiology · 25d
Cleared Jun 09, 2017
1717SGC_127um and 1717SGC_140um
K171419 · MQB
Rayence Co., Ltd.
Radiology · 25d
Cleared Jun 09, 2017
syngo Application Software
K170747 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 91d
Cleared Jun 09, 2017
ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal...
K163313 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 198d