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
6481–6504 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 30, 2010
CAAS QVA 3D, CAAS QCA 3D
K100292 · LLZ
Pie Medical Imaging BV
Radiology · 87d
Cleared Apr 30, 2010
ILUMA VISION MODEL VERSION 2.2
K094064 · LLZ
3M Imtec
Radiology · 120d
Cleared Apr 29, 2010
DOPPLER FETAL HEARTBEAT RATE DETECTOR
K090510 · KNG
Shenzhen Bestman Instrument Co., Ltd.
Radiology · 427d
Cleared Apr 26, 2010
KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM
K093478 · MUH
Trophy
Radiology · 168d
Cleared Apr 26, 2010
VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K092171 · MUH
Genoray Co., Ltd.
Radiology · 279d
Cleared Apr 23, 2010
ERGO IMAGING SYSTEM
K100838 · IYX
Digirad Corp.
Radiology · 30d
Cleared Apr 23, 2010
MINXRAY MODEL CMDR-2S
K100449 · IZL
Minxray, Inc.
Radiology · 65d
Cleared Apr 22, 2010
PRESTODR PORTABLE
K100400 · IZL
Cmt Medical Technologies, Ltd.
Radiology · 65d
Cleared Apr 22, 2010
VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI...
K100113 · MOS
Sentinelle Medical, Inc.
Radiology · 98d
Cleared Apr 22, 2010
LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART
K100096 · IYE
Integra Radionics, Inc.
Radiology · 99d
Cleared Apr 22, 2010
COMPACT TOUCH
K094038 · IYO
Quantel S.A.
Radiology · 113d
Cleared Apr 14, 2010
SYNAPSE OBLIQUUS MIP/MPR/FUSION
K100881 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 15d
Cleared Apr 09, 2010
T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060
K100264 · IYE
Bionix Development Corp.
Radiology · 71d
Cleared Apr 09, 2010
MASTER-VU A-SCAN, MV4500
K100252 · IYO
Sonomed, Inc.
Radiology · 71d
Cleared Apr 08, 2010
XKNIFE 5
K100417 · MUJ
Integra Radionics, Inc.
Radiology · 51d
Cleared Apr 08, 2010
ORS VISUAL
K100335 · LLZ
Object Research Systems, Inc.
Radiology · 62d
Cleared Apr 06, 2010
DIGITAL SPOT MAMMOGRAPHY SYSTEM
K100692 · IZH
Hologic, Inc.
Radiology · 27d
Cleared Apr 05, 2010
S-SCAN, MODEL 9800020010
K100670 · MOS
Esaote, S.P.A.
Radiology · 27d
Cleared Apr 05, 2010
MR INSPIRE WITH EXTENDED KIT
K100164 · LNH
Paramed S.R.L.
Radiology · 75d
Cleared Apr 05, 2010
SIMONDR DRP
K093790 · MQB
Simondr, Inc.
Radiology · 116d
Cleared Apr 05, 2010
MODEL DGH 6000 SCANMATE A
K093371 · IYO
Dgh Technology, Inc.
Radiology · 158d
Cleared Apr 02, 2010
PROXISCAN MODEL 101
K093706 · IYX
Hybridyne Imaging Technologies, Inc.
Radiology · 122d
Cleared Mar 29, 2010
STAIR SYSTEMS PACS & DICOM VIEWER
K100236 · LLZ
Stair Systems, Inc.
Radiology · 62d
Cleared Mar 24, 2010
DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO
K100317 · MUH
VATECH Co., Ltd.
Radiology · 48d