FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
5137–5160 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jan 13, 2014
ULTRABLOX
K133684 · PDK
Bloxr Corporation
Radiology · 42d
Cleared Jan 13, 2014
CT PULMONARY ANALYSIS
K130552 · JAK
Qi Imaging, LLC
Radiology · 315d
Cleared Jan 10, 2014
PROBEAM PROTON THERAPY SYSTEM
K133191 · LHN
Varian Medical Systems
Radiology · 85d
Cleared Jan 10, 2014
ULTRASOUND SCANNER PRO FOCUS 2202
K132346 · IYO
B-K Medical Aps
Radiology · 165d
Cleared Jan 10, 2014
ULTRASOUND SCANNER FLEX FOCUS 1202
K132335 · IYN
B-K Medical Aps
Radiology · 168d
Cleared Jan 07, 2014
ULTRASOUND SCANNER FLEX FOCUS 1202
K132677 · IYN
B-K Medical Aps
Radiology · 132d
Cleared Jan 06, 2014
21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2...
K133686 · LLZ
Jvckenwood Corporation
Radiology · 35d