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
3553–3576 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 30, 2018
Vitrea Software Package
K180323 · LLZ
Canon Medical Systems Corporation
Radiology · 53d
Cleared Mar 30, 2018
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon
K173789 · IWB
Elekta Instrument AB
Radiology · 106d
Cleared Mar 30, 2018
syngo.CT Coronary Analysis
K173637 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 126d
Cleared Mar 30, 2018
SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition...
K173630 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 126d
Cleared Mar 30, 2018
MAGNETOM Vida with Compressed Sensing GRASP-VIBE
K173617 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 128d
Cleared Mar 30, 2018
RADspeed fit
K173517 · KPR
Shimadzu Corporation
Radiology · 136d
Cleared Mar 29, 2018
Voluson P6 and Voluson P8
K180535 · IYN
Ge Healthcare
Radiology · 29d
Cleared Mar 27, 2018
Prelude
K180308 · MUJ
Medcom GmbH
Radiology · 53d
Cleared Mar 23, 2018
ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR,...
K180473 · OWB
Ecotron Co., Ltd.
Radiology · 29d
Cleared Mar 23, 2018
SRT-100+
K173425 · JAD
Sensus Healthcare, Inc.
Radiology · 141d
Cleared Mar 23, 2018
MED-TAB
K173241 · LLZ
Plum Medical Solutions GmbH
Radiology · 168d
Cleared Mar 21, 2018
Emprint Ablation Visualization Application
K180192 · LLZ
Covidien, LLC
Radiology · 56d
Cleared Mar 21, 2018
Mimics inPrint
K173619 · LLZ
Materialise NV
Radiology · 119d
Cleared Mar 21, 2018
SOMATOM Edge Plus
K173607 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 120d
Cleared Mar 21, 2018
Mammomat Revelation
K173408 · MUE
Siemens Medi Cal Solutions, Inc.
Radiology · 140d
Cleared Mar 21, 2018
Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator...
K172611 · JAQ
Varian Medical Systems, Inc.
Radiology · 202d
Cleared Mar 21, 2018
WillCeph
K172168 · LLZ
Hdx Will Corp.
Radiology · 246d
Cleared Mar 21, 2018
P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
K163661 · MOS
Rapid Biomedical GmbH
Radiology · 449d
Cleared Mar 20, 2018
Philips Incisive CT
K180015 · JAK
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 77d
Cleared Mar 20, 2018
Ingenia Elition S and Ingenia Elition X
K173451 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 134d
Cleared Mar 16, 2018
Imbio Segmentation Editing Tool software
K180129 · LLZ
Imbio, LLC
Radiology · 58d
Cleared Mar 16, 2018
syngo Application Software
K173611 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 114d
Cleared Mar 16, 2018
Portable X-ray System
K172928 · EHD
Rolence Enterprise, Inc.
Radiology · 172d
Cleared Mar 15, 2018
AIRO Computed Tomography (CT) X-ray System
K180393 · JAK
Mobius Imaging, LLC
Radiology · 30d