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
2905–2928 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 27, 2019
True 3D Viewer Software
K193149 · LLZ
Echopixel, Inc.
Radiology · 44d
Cleared Dec 27, 2019
Volumetric Specimen Imager
K192939 · MWP
Clarix Imaging
Radiology · 70d
Cleared Dec 27, 2019
Xcam
K192700 · EHD
Hdx Will Corp.
Radiology · 92d
Cleared Dec 27, 2019
Medical Radiation Dosimetry System microSTARii
K192196 · IYE
Landauer
Radiology · 136d
Cleared Dec 20, 2019
Nexus DR Digital X-Ray Imaging System (with vSharp)
K193238 · MQB
Varex Imaging Corporation
Radiology · 25d
Cleared Dec 20, 2019
Ziehm Vision FD
K193230 · OWB
Ziehm Imaging GmbH
Radiology · 25d
Cleared Dec 20, 2019
MRopen EVO
K193116 · LNH
Asg Superconductors S.P.A.
Radiology · 38d
Cleared Dec 20, 2019
BriefCase
K192383 · QAS
Aidoc Medical , Ltd.
Radiology · 112d
Cleared Dec 20, 2019
AVIEW Modeler
K192040 · LLZ
Coreline Soft Co., Ltd.
Radiology · 142d
Cleared Dec 20, 2019
DRX-Evolution with Carestream Digital Tomosynthesis
K191879 · KPR
Carestream Health, Inc.
Radiology · 158d
Cleared Dec 20, 2019
QLAB Advanced Quantification Software
K191647 · QIH
Philips Health Care
Radiology · 183d
Cleared Dec 19, 2019
ZS3 and z.one pro Ultrasound Systems
K192410 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 106d
Cleared Dec 19, 2019
EZER, Portable X-ray System
K190935 · EHD
Livermoretech, Inc.
Radiology · 253d
Cleared Dec 19, 2019
DentiqAir
K183676 · LLZ
3D Industrial Imaging Co., Ltd.
Radiology · 356d
Cleared Dec 19, 2019
uMC 560i
K183144 · OWB
Shanghai United Imaging Healthcare...
Radiology · 401d
Cleared Dec 17, 2019
syngo.CT CaScoring
K192763 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 78d
Cleared Dec 13, 2019
CoreLite X-Ray Specimen Cabinet
K193317 · MWP
Cirdan Imaging Limited
Radiology · 14d
Cleared Dec 13, 2019
CareView 1800Le
K193173 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 25d
Cleared Dec 13, 2019
Deep Learning Image Reconstruction
K193170 · JAK
Ge Healthcare Japan Corporation
Radiology · 28d
Cleared Dec 13, 2019
decimal3D
K192554 · MUJ
.Decimal, LLC
Radiology · 87d
Cleared Dec 13, 2019
QyScore Software
K192531 · LLZ
Qynapse
Radiology · 88d
Cleared Dec 13, 2019
DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ...
K192152 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 126d
Cleared Dec 13, 2019
Icobrain
K192130 · LLZ
Icometrix NV
Radiology · 128d
Cleared Dec 12, 2019
HS50/HS60 Diagnostics Ultrasound System
K192505 · IYN
Samsung Medison Co., Ltd.
Radiology · 91d