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
6241–6264 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 04, 2011
SONOSCAPE ULTRASOUND SYSTEM AND TRANSDUCERS MODEL SSI-8000, 2P1 PHASED ARRAY,...
K102642 · IYN
Sonoscape Company Limited
Radiology · 172d
Cleared Mar 04, 2011
FLAATZ 750E
K102474 · MQB
Drtech Corp.
Radiology · 186d
Cleared Mar 03, 2011
AXIS PACS, HMS PACS
K103679 · LLZ
Axis Health Care, LLC
Radiology · 76d
Cleared Feb 25, 2011
ECHELON RAPID CARDIAC COIL
K110120 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 38d
Cleared Feb 25, 2011
BRACHYTHERAPY NEEDLES, RP SLEEVE, RP BRACHY-SPACER, GOLD MAKERS
K103449 · KXK
Riverpoint Medical
Radiology · 94d
Cleared Feb 25, 2011
ACCUVIX XG DIAGNOSTIC ULTRASOUND SYSTEM
K103397 · IYN
Medison Co., Ltd.
Radiology · 98d
Cleared Feb 25, 2011
TOSHIBA 1.5T EXTRA LARGE KNEE COIL
K103185 · MOS
Quality Electrodynamics
Radiology · 120d
Cleared Feb 18, 2011
MIM 5.2 (BRACHY)
K103576 · LLZ
Mim Software, Inc.
Radiology · 74d
Cleared Feb 18, 2011
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM
K102259 · JAK
VATECH Co., Ltd.
Radiology · 192d
Cleared Feb 17, 2011
G-SCAN
K110238 · LNH
Esaote, S.P.A.
Radiology · 22d
Cleared Feb 17, 2011
ALOKA PROUSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM
K110207 · IYN
Aloka Co., Ltd.
Radiology · 23d
Cleared Feb 17, 2011
BEL-CYPHER N
K110160 · MUH
Takara Belmont Corporation
Radiology · 29d
Cleared Feb 16, 2011
DYNAREX ULTRASOUND GEL
K102637 · MUI
Dynarex Corporation
Radiology · 155d
Cleared Feb 11, 2011
SUPERDIMENSION MARKER DELIVERY KIT
K110093 · JAK
Superdimension, Inc.
Radiology · 30d
Cleared Feb 11, 2011
VISUALIZE: VASCULAR
K103761 · LLZ
The Medipattern Corporation
Radiology · 50d
Cleared Feb 11, 2011
BRIVO MR355, OPTIMA MR360
K103330 · LNH
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 91d
Cleared Feb 11, 2011
1.5T OPTIMA MR430S
K103238 · LNH
Ge Medical Systems, LLC
Radiology · 101d
Cleared Feb 11, 2011
DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP
K102321 · MQB
Samsung Mobile Display Co., Ltd.
Radiology · 178d
Cleared Feb 08, 2011
FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB
K110202 · ITX
Fujifilm Medical System U.S.A., Inc.
Radiology · 15d
Cleared Feb 08, 2011
DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM
K110199 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 15d
Cleared Feb 08, 2011
MEDICAL VISORS MV100
K103507 · LNH
Medical Visors, Inc.
Radiology · 71d
Cleared Feb 08, 2011
VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/...
K101236 · IYN
Ge Healthcare
Radiology · 281d
Cleared Feb 04, 2011
FETAL DOPPLER JPD-100S
K110124 · KNG
Shenzhen Jumper Medical Equipment...
Radiology · 17d
Cleared Feb 04, 2011
MOBILE MIM
K103785 · LLZ
Mim Software, Inc.
Radiology · 39d