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
889–912 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 10, 2024
V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5...
K242511 · IYN
Samsung Medison Co., Ltd.
Radiology · 109d
Cleared Dec 10, 2024
IRISeg
K242461 · QIH
Intuitive Surgical, Inc.
Radiology · 113d
Cleared Dec 10, 2024
DRX-Revolution Mobile X-ray System
K241505 · IZL
Carestream Health, Inc.
Radiology · 196d
Cleared Dec 09, 2024
AutoContour (Model RADAC V4)
K242729 · QKB
Radformation, Inc.
Radiology · 90d
Cleared Dec 09, 2024
Digital Radiography System (ManntiX B, ManntiX K)
K240841 · IZL
Shenzhen Browiner Tech Co., Ltd.
Radiology · 257d
Cleared Dec 06, 2024
SyMRI
K242524 · LNH
Syntheticmr AB (Publ.)
Radiology · 105d
Cleared Dec 06, 2024
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert
K241989 · LLZ
Cercare Medical A/S
Radiology · 151d
Cleared Dec 06, 2024
EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100)
K241923 · QAS
Ever Fortune.Ai, Co., Ltd.
Radiology · 158d
Cleared Dec 06, 2024
MC2 Portable X-ray System
K241567 · OWB
Oxos Medical
Radiology · 189d
Cleared Dec 06, 2024
DrAid™ for Liver Segmentation
K241543 · QIH
Vinbrain Joint Stock Company
Radiology · 189d
Cleared Dec 06, 2024
PeekMed web
K240926 · LLZ
Peek Health, S.A.
Radiology · 246d
Cleared Dec 06, 2024
CDM Insights
K240680 · QIH
Oxford Brain Diagnostics, Ltd.
Radiology · 270d
Cleared Dec 05, 2024
Rapid Surgical Plan (RSP-SW-001)
K243447 · LLZ
Navbit Pty, Ltd.
Radiology · 28d
Cleared Dec 04, 2024
Nanox.ARC
K242395 · IZF
Nano-X Imaging , Ltd.
Radiology · 113d
Cleared Dec 04, 2024
Rextar Pro
K242185 · EHD
Raypia Co., Ltd.
Radiology · 132d
Cleared Dec 04, 2024
XBeam (v2)
K240671 · MUJ
Xstrahl, Ltd.
Radiology · 268d
Cleared Dec 03, 2024
ClearRead CT CAC
K242188 · JAK
Riverain Technologies, Inc.
Radiology · 131d
Cleared Nov 27, 2024
RadiForce RX570
K243221 · PGY
Eizo Corporation
Radiology · 51d
Cleared Nov 27, 2024
HERA W10 Diagnostic Ultrasound System
K242444 · IYN
Samsung Medison Co., Ltd.
Radiology · 103d
Cleared Nov 27, 2024
Sonix Health
K240645 · QIH
Ontact Health Co., Ltd.
Radiology · 265d
Cleared Nov 26, 2024
Intraluminal Applicator Set
K242961 · JAQ
Varian Medical Systems
Radiology · 62d
Cleared Nov 26, 2024
RadUnity (Version 1.0.0)
K242810 · LLZ
Radunity Corp.
Radiology · 69d
Cleared Nov 26, 2024
MROpen Evo (03-2000-00)
K242258 · LNH
Asg Superconductors S.P.A.
Radiology · 118d
Cleared Nov 25, 2024
Transpara (2.1.0)
K241831 · QDQ
Screenpoint Medical B.V.
Radiology · 153d