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
73–96 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 02, 2026
I-View®
K254090 · MUE
Hologic, Inc.
Radiology · 257d
Cleared Sep 01, 2026
RadiForce MX247W
K262783 · PGY
Eizo Corporation
Radiology · 26d
Cleared Sep 01, 2026
MAGNETOM Free.Max
K260758 · LNH
Siemens Shenzhen Magnetic Resonance ,...
Radiology · 176d
Cleared Aug 28, 2026
Rayvolve AZchest
K261378 · QBS
AZmed
Radiology · 123d
Cleared Aug 27, 2026
GC85A
K260481 · KPR
Samsung Electronics Co., Ltd.
Radiology · 195d
Cleared Aug 26, 2026
Heartvue.Proton
K260811 · QIH
Heartvue.ai, Inc.
Radiology · 167d
Cleared Aug 26, 2026
MRIA Radiation Therapy Information System (MRIA)
K260733 · IYE
Manteia Technologies Co., Ltd.
Radiology · 173d
Cleared Aug 25, 2026
Ceevra Reveal 4
K261595 · QIH
Ceevra, Inc.
Radiology · 103d
Cleared Aug 24, 2026
Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo...
K254027 · IYN
Sonoscape Medical Corp.
Radiology · 251d
Cleared Aug 21, 2026
DS Core CBCT Anatomy
K262127 · QIH
Dentsply Sirona
Radiology · 58d
Cleared Aug 21, 2026
BoneMRI
K260584 · QIH
Mriguidance B.V.
Radiology · 182d
Cleared Aug 21, 2026
uAngio AVIVA CX
K253726 · OWB
Shanghai United Imaging Healthcare...
Radiology · 270d
Cleared Aug 19, 2026
Swoop® Portable MR Imaging® System
K262622 · LNH
Hyperfine, Inc.
Radiology · 22d
Cleared Aug 19, 2026
EXTRON 3
K261413 · OWB
DRTECH Corporation
Radiology · 111d
Cleared Aug 18, 2026
Lower Limb AI (LLAI)
K261641 · QIH
AI Planning Logic, Inc.
Radiology · 92d
Cleared Aug 17, 2026
KBA3D (v2.4.0)
K261500 · LLZ
S.M.A.I.O
Radiology · 103d
Cleared Aug 17, 2026
MagicScan-1.5, GreenMR Serenity 1.5T
K254250 · LNH
Xingaoyi Medical Equipment Co.,Ltd
Radiology · 231d
Cleared Aug 14, 2026
AutoContour (RADAC V6)
K262452 · QKB
Radformation, Inc.
Radiology · 28d
Cleared Aug 14, 2026
AdvaView
K262449 · LLZ
ADVAHEALTH SOLUTIONS, LLC
Radiology · 29d
Cleared Aug 14, 2026
Transpara (2.1.0)
K260898 · QDQ
Screenpoint Medical B.V.
Radiology · 149d
Cleared Aug 13, 2026
AIR Recon DL
K253808 · LNH
GE Medical Systems
Radiology · 258d
Cleared Aug 12, 2026
NeuroQuant PET
K261916 · LLZ
Cortechs Labs, Inc.
Radiology · 64d
Cleared Aug 12, 2026
BA-004CC
K261170 · ITX
Fujifilm Corporation
Radiology · 125d
Cleared Aug 12, 2026
CadAI-B Dx
K260086 · QDQ
BeamWorks, Inc.
Radiology · 212d