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
1801–1824 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 24, 2022
AutoContour Model RADAC V2
K220598 · QKB
Radformation, Inc.
Radiology · 175d
Cleared Aug 23, 2022
FONA XDC
K222274 · EHD
Fona S.R.L
Radiology · 25d
Cleared Aug 23, 2022
1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
K222257 · MOS
Invivo Corporation (Business Trade...
Radiology · 27d
Cleared Aug 23, 2022
ClearCheck Model RADCC V2
K220583 · IYE
Radformation, Inc.
Radiology · 175d
Cleared Aug 22, 2022
HS40 Diagnostic Ultrasound System
K221599 · IYN
Samsung Medison Co., Ltd.
Radiology · 81d
Cleared Aug 22, 2022
ClearCalc Model RADCA V2
K220582 · MUJ
Radformation, Inc.
Radiology · 174d
Cleared Aug 19, 2022
MI View&GO
K222172 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 29d
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