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
5161–5184 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 06, 2014
DUAL ENERGY SYSTEM PACKAGE
K132813 · JAK
Toshibamedical Systems Corporation
Radiology · 150d
Cleared Jan 31, 2014
6MP COLOR LCD MONITOR, RADIFORCE RX650
K134002 · LLZ
Eizo Corporation
Radiology · 35d
Cleared Jan 31, 2014
CO PILOT/REGIUS UNITEA
K133730 · LLZ
Konica Minolta, Inc.
Radiology · 56d
Cleared Jan 31, 2014
RADIANCE V2
K133655 · MUJ
Gmv Soluciones Globales Internet S.A.U.
Radiology · 65d
Cleared Jan 31, 2014
VARIAN MULTILEAF COLLIMATOR
K133240 · IYE
Varian Medical Systems, Inc.
Radiology · 102d
Cleared Jan 31, 2014
LOGIQ F SERIES
K133034 · IYN
Ge Healthcare
Radiology · 127d
Cleared Jan 31, 2014
XIRALITE FLOURESCENCE IMAGING SYSTEM X4
K130003 · IZI
Mivenion GmbH
Radiology · 394d
Cleared Jan 30, 2014
DOME S10
K132770 · LLZ
Nds Surgical Imaging
Radiology · 148d
Not Cleared Jan 28, 2014
PROSTATE IMMOBILIZER RECTAL BALLOON
DEN130036 · PCT
Radiadyne
Radiology · 197d
Cleared Jan 27, 2014
1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY
K133986 · MOS
Resonance Innovations, LLC
Radiology · 32d
Cleared Jan 27, 2014
4D INTEGRATED TREATMENT CONSOLE
K133331 · MUJ
Varian Medical Systems, Inc.
Radiology · 90d
Cleared Jan 27, 2014
ATAMA SYSTEM
K132444 · MOS
Monteris Medical,
Radiology · 174d
Cleared Jan 24, 2014
YSIO MAX
K133259 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 93d
Cleared Jan 22, 2014
DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)
K133030 · LLZ
Invivo Corporation
Radiology · 118d
Cleared Jan 21, 2014
ICRCO CLARITY VIEWER
K132499 · LLZ
Icrco, Inc.
Radiology · 165d
Cleared Jan 17, 2014
THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE...
K133875 · LLZ
Ortho Kinematics, Inc.
Radiology · 28d
Cleared Jan 17, 2014
NUVIS DIAGNOSTIC ULTRASOUND SYSTEM
K133833 · IYN
Philips Ultrasound, Inc.
Radiology · 31d
Cleared Jan 17, 2014
SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16
K133424 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 70d
Cleared Jan 17, 2014
XARIO 100
K133277 · IYN
Toshibamedical Systems Corporation
Radiology · 85d
Cleared Jan 17, 2014
GALAXY PLUS
K132921 · MQB
Medien International Co, Ltd.
Radiology · 122d
Cleared Jan 17, 2014
DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W
K132410 · JAK
Ge Medical Systems, LLC
Radiology · 168d
Cleared Jan 15, 2014
COMPUTED RADIOGRAPHY SCANNER
K133120 · MQB
3Disc Americas
Radiology · 107d
Cleared Jan 15, 2014
COMPUTED RADIOGRAPHY SCANNER
K133106 · MQB
3Disc Americas
Radiology · 107d
Cleared Jan 14, 2014
M2 WRIST 2 MRI SYSTEM
K130692 · LNH
Aspect Imaging, Ltd.
Radiology · 307d