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 ×
15,695 results
1873–1896 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 29, 2022
Viz RV/LV
K221100 · QIH
Viz. Ai, Inc.
Radiology · 137d
Cleared Aug 26, 2022
BriefCase
K222277 · QAS
Aidoc Medical , Ltd.
Radiology · 28d
Cleared Aug 25, 2022
MRI Planner
K211841 · MUJ
Spectronic Medical AB
Radiology · 437d
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