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
2305–2328 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 23, 2021
EzOrtho
K211793 · LLZ
Ewoosoft Co., Ltd.
Radiology · 74d
Cleared Aug 20, 2021
Ethos Treatment Management, Ethos Treatment Planning
K212294 · IYE
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Aug 20, 2021
Discovery MI Gen2
K211846 · KPS
Ge Medical Systems, LLC
Radiology · 66d
Cleared Aug 20, 2021
Ez3D-i/E3
K211791 · LLZ
Ewoosoft Co., Ltd.
Radiology · 71d
Cleared Aug 20, 2021
Exo Iris
K211527 · IYN
Exo Imaging, Inc.
Radiology · 95d
Cleared Aug 19, 2021
Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W...
K210317 · IYN
Shantou Institute of Ultrasonic...
Radiology · 197d
Cleared Aug 18, 2021
Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging...
K210318 · IYN
Shantou Institute of Ultrasonic...
Radiology · 196d
Cleared Aug 17, 2021
ROSA Hip System
K210998 · LLZ
Orthosoft D/B/A Zimmer Cas
Radiology · 137d
Cleared Aug 17, 2021
Brain Perfusion (BP) application
K201573 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 432d
Cleared Aug 16, 2021
TruSPECT Radiological Image Processing Station
K212230 · LLZ
Spectrum Dynamics Medical, Ltd.
Radiology · 31d
Cleared Aug 13, 2021
EMM Ultrasonic Transducer Cover
K211969 · ITX
Exact Medical Manufacturing
Radiology · 50d
Cleared Aug 13, 2021
ARCO FP-S
K211777 · OWB
A.T.S. Applicazione Tecnologie...
Radiology · 65d
Cleared Aug 13, 2021
NFLK-2501 Portable X-ray Unit
K211383 · IZL
Neuf, Inc.
Radiology · 101d
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