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
10177–10200 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 17, 1998
HAMAMATSU PET SCANNER, MODEL SHR-22000
K982171 · KPS
Hamamatsu Photonics K.K.
Radiology · 90d
Cleared Sep 14, 1998
PICTOOLS MEDICAL TOOL KIT MODEL 1.0
K982146 · LLZ
Pegasus Imaging Corp.
Radiology · 89d
Cleared Sep 10, 1998
DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000...
K982120 · LLZ
Trex Medical Corp.
Radiology · 86d
Cleared Sep 04, 1998
FLOW 7000 PERIPHERAL VASCULAR COIL
K982339 · MOS
Usa Instruments, Inc.
Radiology · 60d
Cleared Sep 02, 1998
ACQPLAN
K974770 · MUJ
Philips Medical Systems (Cleveland),...
Radiology · 254d
Cleared Sep 02, 1998
NUCAMMA R+
K982044 · KPS
Is2 Research, Inc.
Radiology · 84d
Cleared Sep 02, 1998
NUCAMMA RX
K982045 · KPS
Is2 Research, Inc.
Radiology · 84d
Cleared Sep 02, 1998
VOLUMAX CT IMAGING SYSTEM
K982060 · JAK
Elscint, Inc.
Radiology · 83d
Cleared Sep 02, 1998
TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K982157 · LNH
Field Effects
Radiology · 75d
Cleared Sep 02, 1998
PHILIPS BV300 SERIES RELEASE 2.1
K982706 · OXO
Philips Medical Systems, Inc.
Radiology · 29d
Cleared Sep 01, 1998
VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM
K982345 · JAA
Cardiac Mariners, Inc.
Radiology · 57d
Cleared Aug 27, 1998
IMAGE POST-PROCESSING TECHNIQUES
K980831 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 176d
Cleared Aug 26, 1998
AU5 ULTRASOUND IMAGING SYSTEM
K980468 · IYN
Biosound Esaote, Inc.
Radiology · 201d
Cleared Aug 26, 1998
AQUILION CT SCANNER, MODEL TSX-101A
K982265 · JAK
Toshiba America Medical Systems, In.C
Radiology · 58d
Cleared Aug 25, 1998
C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)
K982442 · IZD
Care Wise Medical Products Corp.
Radiology · 42d
Cleared Aug 21, 1998
SA8800 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS,
K974269 · IYN
Medison America, Inc.
Radiology · 281d
Cleared Aug 21, 1998
ULTRA IMAGE AND ULTRA SCAN
K981028 · ITX
Sonotech, Inc.
Radiology · 155d
Cleared Aug 21, 1998
OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA
K981993 · ODA
The Olympus Optical Co.
Radiology · 74d
Cleared Aug 21, 1998
PEDIATRIC INSTATRAK SYSTEM
K981998 · LLZ
Visualization Technology, Inc.
Radiology · 74d
Cleared Aug 20, 1998
THERMATREK IRIS-3 INFRARED IMAGING SYSTEM
K982112 · LHQ
Thermatrek, Inc.
Radiology · 65d
Cleared Aug 18, 1998
CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS
K982004 · JAK
General Electric Co.
Radiology · 71d
Cleared Aug 18, 1998
DPX-RX BONE DENSITOMETER
K982267 · KGI
Lunar Corp.
Radiology · 50d
Cleared Aug 18, 1998
INFRAMETRICS INFRACAM-MED
K982327 · LHQ
Inframetrics, Inc.
Radiology · 47d
Cleared Aug 07, 1998
INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE...
K974588 · IYN
Rimed , Ltd.
Radiology · 241d