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
5089–5112 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 03, 2014
VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE
K133914 · LHN
Medcom GmbH
Radiology · 101d
Cleared Apr 03, 2014
VIZION ULTRA
K133139 · MQB
Viztek, LLC
Radiology · 168d
Cleared Apr 03, 2014
KOBOLD SECURE LOCK TRANSFER GUIDE TUBE SET
K130757 · JAQ
Spencer Fillmore
Radiology · 379d
Cleared Apr 01, 2014
TABLET VIEWER SOFTWARE FOR IMAGE SUITE
K140271 · LLZ
Carestream Health, Inc.
Radiology · 57d
Cleared Apr 01, 2014
VUPAD
K140199 · IYO
Sonomed, Inc.
Radiology · 64d
Cleared Mar 28, 2014
ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER
K134016 · IYN
Hitachi Aloka Medical,Ltd. (Hitachi...
Radiology · 88d
Cleared Mar 28, 2014
CORONIS 5MP
K133984 · LLZ
Barco N.V.
Radiology · 92d
Cleared Mar 28, 2014
ORTHOSCAN FD MINI C-ARM
K133174 · OXO
Orthoscan, Inc.
Radiology · 162d
Cleared Mar 28, 2014
X-RAY TV SYSTEM SONIAL VISION G4
K131075 · JAA
Shimadzu Corp.
Radiology · 345d
Cleared Mar 28, 2014
AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR
K122298 · IZL
Ajex Meditech., Ltd.
Radiology · 605d
Cleared Mar 27, 2014
PDE-NEO
K133719 · IZI
Hamamatsu Photonics K.K.
Radiology · 112d
Cleared Mar 26, 2014
OP300
K133544 · OAS
Palodex Group OY
Radiology · 128d
Cleared Mar 26, 2014
RESOLUTIONMD MOBILE
K133508 · LLZ
Calgary Scientific, Inc.
Radiology · 132d
Cleared Mar 25, 2014
CAAS WORKSTATION
K133993 · IZI
Pie Medical Imaging
Radiology · 89d
Cleared Mar 25, 2014
ASPIRE CRISTALLE
K133972 · MUE
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 89d
Cleared Mar 25, 2014
NIO COLOR 2MP
K133663 · LLZ
Barco N.V.
Radiology · 116d
Cleared Mar 25, 2014
ASIR-V
K133640 · JAK
Ge Medical Systems, LLC
Radiology · 118d
Cleared Mar 21, 2014
TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM
K140524 · IYN
Teratech Corp.
Radiology · 17d
Cleared Mar 21, 2014
NOVA FA DR SYSTEM
K133782 · MQB
Sedecal., Sa.
Radiology · 99d
Cleared Mar 21, 2014
DISCOVERY PET/CT 710
K133657 · KPS
Ge Medical Systems, LLC
Radiology · 114d
Cleared Mar 20, 2014
MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX...
K140253 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 48d
Cleared Mar 20, 2014
DIGORA OPTIME
K133231 · MUH
Instrumentarium Dental, Palodex Group OY
Radiology · 150d
Cleared Mar 14, 2014
RADIANCE 330 PROTON THERAPY SYSTEM
K134052 · LHN
Protom International, Inc.
Radiology · 73d
Cleared Mar 14, 2014
CS 8100 3D
K133406 · OAS
Trophy
Radiology · 128d