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 × Cleared only ×
15,601 results
3553–3576 of 15,601
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Mar 14, 2018
MR Wireless Gating System, Model WGS-100
K171778 · LNH
Ivy Biomedical Systems, Inc.
Radiology · 272d
Cleared Mar 13, 2018
Voluson S8/ Voluson S10/ Voluson S10 Expert
K180374 · IYN
Ge Healthcare
Radiology · 29d
Cleared Mar 13, 2018
ThinkQA
K180106 · IYE
Dosisoft
Radiology · 56d
Cleared Mar 12, 2018
SICAT Endo
K180262 · LLZ
Sicat GmbH & Co. KG
Radiology · 41d
Cleared Mar 09, 2018
BrightMatter Plan 1.6.0
K180394 · LLZ
Synaptive Medical, Inc.
Radiology · 24d
Cleared Mar 09, 2018
Quantib Brain
K173939 · LLZ
Quantib B.V.
Radiology · 73d
Cleared Mar 08, 2018
icobrain
K180326 · LLZ
Icometrix
Radiology · 30d
Cleared Mar 08, 2018
HS70A Diagnostic Ultrasound System
K173713 · IYN
Samsung Medison Co., Ltd.
Radiology · 94d
Cleared Mar 08, 2018
syngo.CT Clinical Extensions
K173625 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 104d
Cleared Mar 08, 2018
iQMR
K173605 · LLZ
Medic Vision - Imaging Solutions, Ltd.
Radiology · 107d
Cleared Mar 07, 2018
PORT-X IV
K172810 · EHD
Genoray Co., Ltd.
Radiology · 170d
Cleared Mar 06, 2018
Ingenia Elition S and Ingenia Elition X R5.4
K173356 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 132d
Cleared Mar 02, 2018
COMPACT TOUCH Ophthalmic Ultrasound System
K180265 · IYO
Quantel Medical
Radiology · 30d