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
2329–2352 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 12, 2021
eVolve PACS
K211863 · LLZ
Evolve Pacs, Inc.
Radiology · 57d
Cleared Aug 12, 2021
InferRead CT Stroke.AI
K211179 · QAS
Infervision Medical Technology Co., Ltd.
Radiology · 114d
Cleared Aug 12, 2021
Excelsius3D
K210912 · OWB
Globus Medical, Inc.
Radiology · 136d
Cleared Aug 11, 2021
uCT ATLAS with uWS-CT-Dual Energy Analysis
K203448 · JAK
Shanghai United Imaging Healthcare...
Radiology · 261d
Cleared Aug 10, 2021
EAGLE EDGE AXR90 and AXR120
K210820 · OAS
Alliage S/A Industrias Medico...
Radiology · 144d
Cleared Aug 09, 2021
X-CUBE 90
K211300 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 103d
Cleared Aug 09, 2021
X-CUBE 70
K211299 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 103d
Cleared Aug 06, 2021
Kosmos
K212100 · IYN
EchoNous, Inc.
Radiology · 31d
Cleared Aug 06, 2021
Vereos PET/CT
K211764 · KPS
Philips Medical Systems Nederland B.V.
Radiology · 59d
Cleared Aug 06, 2021
Senographe Pristina
K211725 · MUE
Ge Healthcare
Radiology · 63d
Cleared Aug 04, 2021
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
K212056 · LNH
Canon Medical Systems Corporation
Radiology · 34d
Cleared Aug 03, 2021
Remex KA6
K212144 · IZL
Remedi Co., Ltd.
Radiology · 25d
Cleared Aug 02, 2021
DynaCAD
K212175 · LLZ
Invivo Corporation
Radiology · 21d
Cleared Aug 02, 2021
breastscape v1.0
K211431 · QIH
Olea Medical
Radiology · 87d
Cleared Jul 30, 2021
FibroScan 230
K212035 · IYO
Echosens
Radiology · 30d
Cleared Jul 30, 2021
DX-D Imaging Package with XD Detectors
K211790 · MQB
Agfa N.V.
Radiology · 50d
Cleared Jul 30, 2021
syngo.via RT Image Suite
K211379 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 87d
Cleared Jul 30, 2021
qER-Quant
K211222 · QIH
Qure.Ai Technologies
Radiology · 98d
Cleared Jul 30, 2021
Labat series Diagnostic Ultrasound System
K210154 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 190d
Cleared Jul 29, 2021
Zap-X Radiosurgical System
K211663 · IYE
Zap Surgical Systems, Inc.
Radiology · 58d
Cleared Jul 29, 2021
CRUXVIEW
K211317 · MUH
Cruxell Corp.
Radiology · 90d
Cleared Jul 28, 2021
Portray
K211014 · EHD
Surround Medical Systems
Radiology · 114d
Cleared Jul 27, 2021
ClariCT.AI
K212074 · LLZ
Claripi, Inc.
Radiology · 25d
Cleared Jul 27, 2021
aPROMISE
K211655 · LLZ
Exini Diagnostics AB
Radiology · 60d