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
817–840 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 11, 2025
Vivid T9/Vivid T8
K243628 · IYN
GE Medical Systems Ultrasound and...
Radiology · 78d
Cleared Feb 11, 2025
Vivid iq
K243620 · IYN
GE Medical Systems Ultrasound and...
Radiology · 81d
Cleared Feb 10, 2025
Ultrasound Workspace (UWS 6.0)
K241659 · QIH
Philips Ultrasound, LLC
Radiology · 245d
Cleared Feb 07, 2025
Identify (4.0)
K242957 · IYE
Varian Medical Systems, Inc.
Radiology · 135d
Cleared Feb 06, 2025
EPIQ Series Diagnostic Ultrasound System
K243794 · IYN
Philips Ultrasound, LLC
Radiology · 58d
Cleared Feb 05, 2025
BoneMetrics (US)
K241593 · QIH
Gleamer Sas
Radiology · 247d
Cleared Feb 04, 2025
rTOP
K243333 · LLZ
Roclub GmbH
Radiology · 103d
Cleared Feb 03, 2025
Contour ProtégéAI+
K250035 · QKB
Mim Software, Inc.
Radiology · 27d
Cleared Jan 31, 2025
ZeTTA PACS
K241694 · LLZ
Tae Young Soft Co., Ltd.
Radiology · 233d
Cleared Jan 27, 2025
Bunkerhill AVC
K243229 · JAK
BunkerHill Health
Radiology · 111d
Cleared Jan 27, 2025
Imaging system of positron emission and X-ray computed tomography (DigitMI 930)
K241266 · KPS
Raysolution Healthcare Co., Ltd.
Radiology · 266d
Cleared Jan 23, 2025
TeraRecon Aorta.CT (1.1.0)
K243158 · QIH
Terarecon,Inc.
Radiology · 115d
Cleared Jan 23, 2025
CephNinja
K241819 · LLZ
Cyncronus, LLC
Radiology · 213d
Cleared Jan 22, 2025
Rapid Neuro3D
K243350 · QIH
Ischemaview, Inc.
Radiology · 86d
Cleared Jan 21, 2025
Ziehm Vision RFD 3D
K243303 · OWB
Ziehm Imaging GmbH
Radiology · 92d
Cleared Jan 17, 2025
Aurora
K243605 · KPS
Ge Medical Systems Israel, Functional...
Radiology · 57d
Cleared Jan 17, 2025
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)
K243502 · IYN
Olympus Medical Systems Corporation
Radiology · 66d
Cleared Jan 17, 2025
TBS iNsight (V4)
K243218 · KGI
Medimaps Group SA
Radiology · 105d
Cleared Jan 17, 2025
Prenuvo Body Composition
K242825 · LNH
Prenuvo
Radiology · 121d
Cleared Jan 17, 2025
TechCare Trauma
K242171 · QBS
Milvue
Radiology · 177d
Cleared Jan 17, 2025
Digital Color Doppler Ultrasound System (P60 Series)
K241949 · IYN
Sonoscape Medical Corp.
Radiology · 198d
Cleared Jan 16, 2025
Second Opinion CC
K242522 · MYN
Pearl, Inc.
Radiology · 146d
Cleared Jan 16, 2025
VIVIX-M
K241113 · MUE
Vieworks Co., Ltd.
Radiology · 269d
Cleared Jan 15, 2025
Ziehm Vision RFD
K243328 · OWB
Ziehm Imaging GmbH
Radiology · 83d