Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Radiology × Cleared only ×
15,676 results
1873–1896 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 19, 2022
AXIR-CX
K213520 · LLZ
Radisen Co., Ltd.
Radiology · 289d
Cleared Aug 17, 2022
WebCeph
K220903 · LLZ
Assemblecircle Corp.
Radiology · 142d
Cleared Aug 16, 2022
ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select...
K221190 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 113d
Cleared Aug 16, 2022
syngo Application Software (VE21)
K220433 · LLZ
Siemens Medical Solution USA, Inc.
Radiology · 182d
Cleared Aug 12, 2022
EzDent-i / E2 / Prora View/ Smart M Viewer
K222145 · LLZ
Ewoosoft Co., Ltd.
Radiology · 23d
Cleared Aug 12, 2022
TeraRecon Neuro
K220349 · LLZ
Terarecon,Inc.
Radiology · 186d
Cleared Aug 11, 2022
Medical image processing software
K220910 · JAK
Hangzhou Deepwise & League of PHD...
Radiology · 135d
Cleared Aug 11, 2022
AI-Rad Companion (Pulmonary)
K213713 · JAK
Siemens Healthcare GmbH
Radiology · 260d
Cleared Aug 08, 2022
Dolphin Imaging 12.0
K222072 · LLZ
Patterson Dental Supply, Inc.
Radiology · 25d
Cleared Aug 08, 2022
dS Sentinelle Breast 16ch 1.5T Coil
K213735 · MOS
Invivo Corporation (Business Trade...
Radiology · 252d
Cleared Aug 08, 2022
dS Sentinelle Breast 16ch 3.0T Coil
K213727 · MOS
Invivo Corporation (Business Trade...
Radiology · 255d
Cleared Aug 08, 2022
ClearPoint Maestro Brain Model
K213645 · QIH
ClearPoint Neuro, Inc.
Radiology · 263d
Cleared Aug 05, 2022
Neurophet SCALE PET
K221405 · LLZ
Neurophet., Inc.
Radiology · 81d
Cleared Aug 03, 2022
Customize
K221432 · QIH
3D-Side S.A.
Radiology · 78d
Cleared Aug 03, 2022
Transpara 1.7.2
K221347 · QDQ
Screenpoint Medical B.V.
Radiology · 86d
Cleared Aug 01, 2022
X-ray Flat Panel Detectors (CareView 1800 RF)
K221549 · MQB
Careray Digital Medical Technology...
Radiology · 62d
Cleared Jul 29, 2022
Deep Learning Image Reconstruction
K220961 · JAK
Ge Healthcare Japan Corporation
Radiology · 119d
Cleared Jul 29, 2022
ABMD Software
K213760 · KGI
HeartLung Corporation
Radiology · 240d
Cleared Jul 28, 2022
Swoop Portable MR Imaging System
K221923 · LNH
Hyperfine, Inc.
Radiology · 27d
Cleared Jul 28, 2022
Trinias
K221922 · OWB
Shimadzu Corporation Medical Systems...
Radiology · 27d
Cleared Jul 28, 2022
TRON
K221230 · OWB
Xoran Technologies, LLC
Radiology · 90d
Cleared Jul 28, 2022
cvi42 Auto Imaging Software Application
K213998 · QIH
Circle Cardiovascular Imaging, Inc.
Radiology · 219d
Cleared Jul 27, 2022
OTC DDR
K221853 · KPR
Konica Minolta Healthcare Americas, Inc.
Radiology · 30d
Cleared Jul 26, 2022
LCD monitor (HMD3C21S), LCD monitor (HMD5G21S)
K221567 · PGY
Qingdao Hisense Medical Equipment...
Radiology · 56d