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
10297–10320 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Aug 07, 1998
SONOPSY LA SYSTEM
K980423 · IYO
Neovision Corp.
Radiology · 185d
Cleared Aug 07, 1998
IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW
K981790 · IYE
Elekta Oncology Systems, Ltd.
Radiology · 79d
Cleared Aug 07, 1998
DIAGNOSTIC ULTRASOUND SYSTEM
K982498 · IYN
Volumetrics Medical Imaging, Inc.
Radiology · 21d
Cleared Aug 07, 1998
CAREDOP II
K982635 · JAF
Nicolet Biomedical
Radiology · 25d
Cleared Aug 03, 1998
ORTHOVU-1000
K981898 · LNH
Magnevu
Radiology · 63d
Cleared Jul 31, 1998
IMAGEQUEST
K974707 · LMD
Visual Med, Inc.
Radiology · 227d
Cleared Jul 31, 1998
HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC...
K981397 · IYN
Toshiba America Medical Systems, In.C
Radiology · 105d
Cleared Jul 31, 1998
OUTLOOK LARGE PHASED ARRAY NECK COIL
K981959 · MOS
Philips Medical Systems (Cleveland),...
Radiology · 57d
Cleared Jul 31, 1998
IMAGYN 125 I SEED, MODEL IS 125
K982421 · IWG
International Isotopes, Inc.
Radiology · 18d
Cleared Jul 31, 1998
GENESIS IMRT LINEAR ACCELERATOR
K982502 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 11d
Cleared Jul 31, 1998
MX MEVATRON
K982513 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 11d
Cleared Jul 27, 1998
PHOTON RADIOSURGERY SYSTEM PRS400
K980526 · JAD
Pec Photoelectron Corp.
Radiology · 167d
Cleared Jul 27, 1998
EUP-OL334 LAPARASCOPICPROBE
K981434 · ITX
Hitachi Medical Corp. of America
Radiology · 97d
Cleared Jul 24, 1998
MOBETRON
K981112 · LHN
Intraop Medical, Inc.
Radiology · 120d
Cleared Jul 20, 1998
PRO VISION
K980648 · LLZ
Algotec Systems, Ltd.
Radiology · 151d
Cleared Jul 17, 1998
NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM
K981424 · IYE
Nomos Corp.
Radiology · 88d
Cleared Jul 17, 1998
MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST,...
K981641 · IZH
Instrumentarium Corp.
Radiology · 70d
Cleared Jul 16, 1998
CERVIX COIL LATEX SHEATH
K981406 · MOS
Philips Medical Systems (Cleveland),...
Radiology · 87d
Cleared Jul 16, 1998
LC POSITIONER
K981414 · JAA
Fischer Imaging Corp.
Radiology · 87d