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
5449–5472 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 01, 2013
MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS
K123426 · LLZ
Orpheus Medical , Ltd.
Radiology · 114d
Cleared Mar 01, 2013
REXTAR, REXTAR LCD
K122016 · EHD
Meta Biomed, Inc.
Radiology · 234d
Cleared Feb 27, 2013
XOFT AXXENT CERVICAL APPLICATORS
K123442 · JAQ
Icad, Inc.
Radiology · 111d
Cleared Feb 26, 2013
ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM
K123529 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 102d
Cleared Feb 26, 2013
CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE
K123433 · KPS
Cedars-Sinai Medical Center
Radiology · 111d
Cleared Feb 25, 2013
ACHILLES
K123238 · MUA
Ge Medical Systems China Co., Ltd.
Radiology · 132d
Cleared Feb 25, 2013
VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING
K122578 · LLZ
Vital Images, Inc.
Radiology · 186d
Cleared Feb 22, 2013
ENDOSCOPIC ULTRASOUND CENTER EU-Y0008
K130058 · IYN
Olympus Medical Systems Corp.
Radiology · 44d
Cleared Feb 22, 2013
EOS
K123740 · MQB
Eos Imaging
Radiology · 79d
Cleared Feb 22, 2013
1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
K123681 · MOS
Wipro GE Healthcare Private, Ltd.
Radiology · 84d
Cleared Feb 22, 2013
EMORY CARDIAC TOOLBOX 4.0
K123646 · KPS
Syntermed, Inc.
Radiology · 87d
Cleared Feb 22, 2013
MAMMOMAL INSPIRATION
K122286 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 207d
Cleared Feb 21, 2013
VERIFICATION CONSOLE
K124002 · LHN
Varian Medical Systems
Radiology · 57d
Cleared Feb 20, 2013
ARIX RAD ACQUISITION CONSOLE
K123650 · LLZ
Compania Mexicana DE Radiologia Cgr,...
Radiology · 85d
Cleared Feb 20, 2013
MDU5 PLUS STERILE BAG
K123424 · ITX
Boston Scientific Corp
Radiology · 105d
Cleared Feb 19, 2013
MAMMOWORKSTATION
K123575 · LLZ
Image Diagnost International GmbH
Radiology · 91d
Cleared Feb 19, 2013
COMMUNIFY PACS VIEWER
K120851 · LLZ
Communify Health, LLC
Radiology · 335d
Cleared Feb 15, 2013
CPI RAD VISION
K122726 · KPR
Communications & Power Industries...
Radiology · 163d
Cleared Feb 15, 2013
TRANSCRANIAL DOPPLER WITH ROBOTIC PROBE HEADBAND
K122710 · IYN
Shenzhen Delicate Electronics Co., Ltd.
Radiology · 164d
Cleared Feb 13, 2013
ULTRASOUND SCANNER FLEX FOCUS
K123254 · IYN
B-K Medical Aps
Radiology · 118d
Cleared Feb 13, 2013
DOSE TRACKING SYSTEM MODEL XIDF-DTS801
K123097 · JAA
Toshiba America Medical Systems, In.C
Radiology · 134d
Cleared Feb 12, 2013
SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR...
K123938 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 54d
Cleared Feb 08, 2013
CORONIS FUSION 6MP
K130103 · LLZ
Barco N.V.
Radiology · 24d
Cleared Feb 08, 2013
4MP COLOR LCD MONITOR, RADIFORCE RX440
K130070 · LLZ
Eizo Nanao Corporation
Radiology · 28d