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
5329–5352 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 15, 2013
DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS
K132341 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 20d
Cleared Aug 15, 2013
ORTHOVISION
K131570 · LLZ
Ewoosoft Co., Ltd.
Radiology · 77d
Cleared Aug 15, 2013
LVIVO EF SYSTEM
K130779 · LLZ
Diacardio, Ltd.
Radiology · 147d
Cleared Aug 09, 2013
QLAB QUANTIFICATION SOFTWARE
K132165 · LLZ
Philips Ultrasound, Inc.
Radiology · 28d
Cleared Aug 07, 2013
ACTIVE BREATHING COORDINATOR
K131313 · IYE
Aktina Medical Corp.
Radiology · 92d
Cleared Aug 06, 2013
THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0
K130743 · LLZ
Ortho Kinematics, Inc.
Radiology · 140d
Cleared Aug 05, 2013
EPIDOSE
K131704 · IYE
Sun Nuclear Corporation
Radiology · 55d
Cleared Aug 01, 2013
CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED PROBE
K131305 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 86d
Cleared Aug 01, 2013
ENDOGRAPH DC
K130109 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 197d
Cleared Jul 31, 2013
REXTAR X
K132041 · EHD
Meta Biomed, Inc.
Radiology · 29d
Cleared Jul 30, 2013
CURA COMPENSATOR
K131150 · IXI
Cura Medical Technologies, LLC
Radiology · 98d
Cleared Jul 26, 2013
3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND...
K131448 · LLZ
Koelis
Radiology · 67d
Cleared Jul 25, 2013
IQQA-LIVER MULTIMODALITY SOFTWARE
K131498 · LLZ
Edda Technology, Inc.
Radiology · 62d
Cleared Jul 25, 2013
DUOFLEX COIL SUITE (1.5T)
K130706 · MOS
Mr Instruments, Inc.
Radiology · 132d
Cleared Jul 24, 2013
PERCUNAV SYSTEM
K132087 · JAK
Philips Health Care
Radiology · 19d
Cleared Jul 24, 2013
M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
K131690 · IYO
Shenzhen Mindray Bio-Medical...
Radiology · 44d
Cleared Jul 24, 2013
XPERGUIDE
K131263 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 82d
Cleared Jul 23, 2013
ESIE APPS SUITE
K132062 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Jul 23, 2013
ULTRAEXTEND USWS-900A V2.1 AND V3.1
K131822 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 33d
Cleared Jul 19, 2013
ELIXBO PM545
K130658 · LNH
Xbo Medical Systems Co., Ltd.
Radiology · 129d
Cleared Jul 18, 2013
SOLID GEL PAD
K131905 · MUI
Bluemtech
Radiology · 22d
Cleared Jul 18, 2013
21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)
K131137 · LLZ
Jvckenwood Corporation
Radiology · 86d
Cleared Jul 18, 2013
ICT
K130224 · JAK
Imris, Inc.
Radiology · 170d
Cleared Jul 18, 2013
PORT VIEW, DIGITAL X-RAY SENSOR SYSTEM
K130088 · MUH
Genoray Co., Ltd.
Radiology · 185d