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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,488 results
10249–10272 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 12, 1998
FRACTURE RISK ASSESSMENT CAPABILITY FOR NORLAND X-RAY BONE DENSITOMETERS
K980569 · KGI
Norland Corp.
Radiology · 119d
Cleared Jun 12, 1998
VARIAN XIMATRON SCAN VISION CT
K981056 · KPR
Varian Medical Systems, Inc.
Radiology · 81d
Cleared Jun 08, 1998
PERCEPTION GPS-RST DIAGNOSTIC ULTRASOUND SYSTEM
K974880 · IYO
Perception, Inc.
Radiology · 160d
Cleared Jun 08, 1998
MUCHECK MONITOR UNIT VALIDATION PROGRAM
K980904 · IYE
Medical Dosimetry Services, Inc.
Radiology · 90d
Cleared Jun 08, 1998
IIRAD DIRECTRAY OPERATOR CONSOLE
K980970 · LLZ
Sterling Diagnostic Imaging, Inc.
Radiology · 84d
Cleared Jun 08, 1998
E.CAM LSO 311 PET/SPECT SYSTEM
K981027 · KPS
Cti Pet Systems, Inc.
Radiology · 81d
Cleared Jun 04, 1998
3D-MSPECT
K980867 · KPS
Adac Laboratories
Radiology · 90d
Cleared Jun 04, 1998
EMORY CARDIAC TOOL BOX
K980914 · KPS
Emory University
Radiology · 85d
Cleared Jun 04, 1998
VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA...
K980959 · KPS
Ge Medical Systems F.I. Haifa
Radiology · 82d
Cleared Jun 04, 1998
ACCUDEXA BONE DENSITOMETER
K981124 · KGI
Schick Technologies, Inc.
Radiology · 69d
Cleared Jun 03, 1998
CT SCOPE
K974344 · JAK
Elscint, Inc.
Radiology · 196d
Cleared Jun 03, 1998
JPACS
K980918 · LMD
Philips Medical Systems (Cleveland),...
Radiology · 84d
Cleared Jun 01, 1998
FOCUS RTP SYSTEM
K973936 · IYE
Computerized Medical Systems, Inc.
Radiology · 229d
Cleared Jun 01, 1998
EQUIDOSE SOLID STATE DIODE DETECTORS
K980826 · IYE
Cii Mastek, Inc.
Radiology · 90d
Cleared Jun 01, 1998
ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM
K981398 · LNH
Interneuron Pharmaceuticals, Inc.
Radiology · 45d
Cleared May 27, 1998
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
K981626 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared May 22, 1998
DOWNSCAN LT
K974882 · LMD
Merlin Engineering Works, Inc.
Radiology · 143d
Cleared May 22, 1998
SONOS 5500 ULTRASOUND IMAGING SYSTEM
K980687 · IYO
Hewlett-Packard Co.
Radiology · 88d
Cleared May 20, 1998
PINPOINT
K974513 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 170d
Cleared May 20, 1998
REFERENCE POPULATION FOR NORLAND APOLLO X-RAY BONE DENSITOMETER
K980125 · KGI
Norland Corp.
Radiology · 126d
Cleared May 20, 1998
RADIOCAMERAS PATIENT POSITIONING SYSTEM
K980750 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 83d
Cleared May 20, 1998
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS
K980837 · JAK
Shimadzu Medical Systems
Radiology · 77d
Cleared May 20, 1998
FUKUDA DENSHI ULTRASOUND SCANNERS MODELS UF-3500 AND UF-4500
K981404 · IYO
Fukuda Denshi USA, Inc.
Radiology · 33d
Cleared May 18, 1998
PROWESS PRO-SIM
K980379 · IYE
Ssgi Prowess Systems
Radiology · 108d