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
10369–10392 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 29, 1998
VANTAGE 3.0 INSYNCH
K981291 · KPS
Adac Laboratories
Radiology · 81d
Cleared Jun 26, 1998
PATHFINDER MOBILE C ARM
K981131 · OXO
Acoma Medical Imaging, Inc.
Radiology · 88d
Cleared Jun 25, 1998
RADIO-PLAST
K981115 · LHN
Smith & Nephew, Inc.
Radiology · 90d
Cleared Jun 19, 1998
KONICA DIRECT DIGITIZER REGIUS MODEL 330
K980873 · LMA
Konica Corp.
Radiology · 105d
Cleared Jun 19, 1998
WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE
K981470 · IZH
Worldwide Medical Technologies, LLC
Radiology · 57d
Cleared Jun 18, 1998
KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW
K981053 · LMD
Eastman Kodak Company
Radiology · 87d
Cleared Jun 18, 1998
MEDRAD NEUROVASCULAR COIL
K981094 · MOS
Medrad, Inc.
Radiology · 84d
Cleared Jun 18, 1998
PLATINUM READING, REVIEW & ANALYSIS WORKSTATION
K981217 · LLZ
GE Medical Systems
Radiology · 76d
Cleared Jun 18, 1998
PHILIPS THORAVISION
K981657 · KPR
Philips Medical Systems North...
Radiology · 38d
Cleared Jun 17, 1998
COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO
K973864 · IZF
Pausch Corp.
Radiology · 251d
Cleared Jun 17, 1998
THE NETWORK SYSTEM
K980234 · LLZ
Medical Sni , Ltd.
Radiology · 146d
Cleared Jun 12, 1998
FRACTURE RISK ASSESSMENT FOR THE NORLAND SXA 3000 BONE DENSITOMETER
K980289 · KGI
Norland Corp.
Radiology · 137d
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