FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,601 results
1–24 of 15,601
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Aug 10, 2026
EM-TECH Passive Ultrasound Probe Strap
K254143 · ITX
EM-TECH Solutions, Inc.
Radiology · 231d
Cleared Aug 10, 2026
Prostate Core
K253794 · QIH
Lucida Medical, Ltd.
Radiology · 255d
Cleared Aug 07, 2026
Venue Go
K261668 · IYN
GE Medical Systems Ultrasound and...
Radiology · 79d