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
10393–10416 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared May 11, 1998
PHILIPS GYROSCAN NT RELEASE 6 SERIES
K980645 · LNH
Philips Medical Systems North...
Radiology · 81d
Cleared May 11, 1998
AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K980691 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 77d
Cleared May 11, 1998
LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER
K980809 · LMA
Lumisys, Inc.
Radiology · 69d
Cleared May 08, 1998
COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM
K981505 · IYO
Sonosite,Inc.
Radiology · 14d
Cleared May 08, 1998
SONOACE 6000/ ULTRAMARK 400
K981510 · IYO
Medison America, Inc.
Radiology · 10d
Cleared May 06, 1998
DIFFUSION PACKAGE / GYROSCAN NT
K973658 · LNH
Philips Medical Systems North...
Radiology · 223d
Cleared May 06, 1998
ECHOTECH 3D FREESCAN
K980308 · IYO
Echotech 3D Imaging Systems GmbH
Radiology · 99d
Cleared May 06, 1998
VSS, VIRTUAL SIMULATION SYSTEM
K980629 · IYE
Nucletron Corp.
Radiology · 77d
Cleared May 06, 1998
VR NETSERVE
K980684 · LMD
I.S.G. Technologies, Inc.
Radiology · 72d
Cleared May 06, 1998
AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS)
K980715 · KPS
Adac Laboratories
Radiology · 71d
Cleared May 06, 1998
FACTS MONOBLOCK
K981267 · IZX
Dynarad Corp.
Radiology · 29d
Cleared May 04, 1998
MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T...
K980417 · LNH
Medrad, Inc.
Radiology · 90d