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
7129–7152 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 25, 2008
ACUSON X300 ULTRASOUND SYSTEM
K080760 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 38d
Cleared Apr 25, 2008
SYNGO DYNAMICS VERSION 7.0
K081018 · LLZ
Siemens Medical Solutions
Radiology · 15d
Cleared Apr 25, 2008
SIGNA 3.0T MR750 SYSTEM
K081028 · LNH
Ge Medical Systems, LLC
Radiology · 14d
Cleared Apr 22, 2008
SYNGO MULTIMODALITY WORKPLACE
K072728 · LLZ
Siemens AG Medical Solutions
Radiology · 209d
Cleared Apr 22, 2008
DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI
K080351 · LLZ
Dexela, Ltd.
Radiology · 71d
Cleared Apr 18, 2008
FCR GO PORTABLE DIGITAL X-RAY SYSTEM
K080945 · IZL
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 15d
Cleared Apr 18, 2008
NM APPLICATION SUITE
K080961 · LLZ
Philips Nuclear Medicine, Inc.
Radiology · 14d
Cleared Apr 17, 2008
DIGITAL LIGHTBOX
K080608 · LLZ
Brainlab AG
Radiology · 44d
Cleared Apr 16, 2008
SURGICASE
K073449 · LLZ
Materialise NV
Radiology · 128d
Cleared Apr 16, 2008
DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16
K080553 · KPR
Vieworks Co., Ltd.
Radiology · 48d
Cleared Apr 16, 2008
ONCENTRA GYN
K080929 · MUJ
Nucletron Corporation
Radiology · 15d
Cleared Apr 11, 2008
NAVSTATIONIRAD EMT, VERSION 1.1
K080624 · JAK
Cas Innovations AG
Radiology · 37d
Cleared Apr 11, 2008
BRIGHTVIEW VCT IMAGING SYSTEM
K080927 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 9d
Cleared Apr 09, 2008
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17
K073695 · JAK
J. Morita USA, Inc.
Radiology · 100d
Cleared Apr 09, 2008
IMAGENMD WITH IMAGENQ
K080770 · LLZ
Cardiovascular Imaging Technologies, LLC
Radiology · 22d
Cleared Apr 08, 2008
DENTAL DIGITAL X-RAY IMAGING SYSTEM
K073365 · MUH
VATECH Co., Ltd.
Radiology · 130d
Cleared Apr 08, 2008
VERAVIEWEPOCS
K073696 · MUH
J. Morita USA, Inc.
Radiology · 99d
Cleared Apr 08, 2008
IGROK
K080325 · LLZ
Igrok, LLC
Radiology · 62d
Cleared Apr 07, 2008
ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM
K080800 · IYN
Medison Co., Ltd.
Radiology · 17d
Cleared Apr 04, 2008
MODIFICATION TO: SAVI APPLICATOR KIT
K080565 · JAQ
Cianna Medical, Inc.
Radiology · 35d
Cleared Apr 02, 2008
MIMICS
K073468 · LLZ
Materialise NV
Radiology · 114d
Cleared Apr 02, 2008
WBR XPRESS.CARDIAC, WBR XPRESS.BONE
K080784 · KPS
Ultraspect , Ltd.
Radiology · 13d
Cleared Apr 02, 2008
TEM 3002G- HN DUAL TUNE HEAD COIL
K080820 · MOS
Mr Instruments, Inc.
Radiology · 9d
Cleared Mar 31, 2008
INREACH SYSTEM
K080271 · JAK
Superdimension, Ltd.
Radiology · 59d