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
49–72 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 18, 2026
Elucid PlaqueIQ
K261855 · LLZ
Elucid Bioimaging, Inc.
Radiology · 107d
Cleared Sep 18, 2026
SCENARIA View Phase 6.0
K261229 · JAK
Fujifilm Corporation
Radiology · 156d
Cleared Sep 16, 2026
AerFrame™ Alignment Laser Box (LBV2)
K261865 · IYE
Stabilix, LLC
Radiology · 104d
Cleared Sep 16, 2026
Embrace Vision Neonatal MRI System
K261758 · LNH
Aspect Imaging, Ltd.
Radiology · 111d
Cleared Sep 16, 2026
EchoPAC Software Only / EchoPAC Plug-in (v211)
K261623 · QIH
GE Medical Systems Ultrasound and...
Radiology · 124d
Cleared Sep 16, 2026
APERTO Lucent MRI System
K261283 · LNH
Fujifilm Corporation
Radiology · 152d
Cleared Sep 16, 2026
a2z-Abdo-Triage
K260906 · QAS
A2z Radiology Ai, Inc.
Radiology · 181d
Cleared Sep 15, 2026
SPINEsim v1.0
K261861 · LLZ
Mdsim S.A.
Radiology · 103d
Cleared Sep 15, 2026
Artificial Intelligence Renal Assessment (AIRA) Version 1
K261677 · QIH
Aramis Global AI Consultancies, LLC
Radiology · 117d
Cleared Sep 15, 2026
OOOPDS
K254214 · LLZ
Taiwan Main Orthopaedic Biotechnology...
Radiology · 260d
Cleared Sep 14, 2026
qCT Lung (v1.0)
K261517 · QDQ
Qure.Ai Technologies Pvt. , Ltd.
Radiology · 130d
Cleared Sep 14, 2026
Hand-held Dental X-ray System (HyperLight-M)
K260795 · EHD
Changzhou Sifary Medical Technology...
Radiology · 187d
Cleared CT Sep 11, 2026
SpaceOAR Flex™ System
K262151 · OVB
Boston Scientific Corporation
Radiology · 78d
Cleared Sep 11, 2026
MICSI-PET
K261305 · KPS
Microstructure Imaging, Inc.
Radiology · 144d
Cleared Sep 11, 2026
BoneVue
K254072 · KGI
Curvebeam AI / Curvebeam, LLC
Radiology · 267d
Cleared Sep 10, 2026
Quicktome Software Suite
K261795 · QIH
Omniscient Neurotechnology Pty, Ltd.
Radiology · 104d
Cleared Sep 10, 2026
4DM
K260879 · QIH
INVIA, LLC
Radiology · 177d
Cleared Sep 09, 2026
ChestView US (1.1)
K252486 · MYN
Gleamer
Radiology · 398d
Cleared Sep 09, 2026
ReVISION 2
K251417 · QIH
Argus Cognitive, Inc.
Radiology · 490d
Cleared Sep 08, 2026
EXSYS DEXi (EXSYS DEXi-S40S)
K260227 · KPR
DRTECH Corporation
Radiology · 225d
Cleared Sep 04, 2026
3D-RD-S
K262060 · LLZ
Radiopharmaceutical Imaging &...
Radiology · 78d
Cleared Sep 04, 2026
NextMR Spine
K260525 · QIH
MRI2CT, Inc.
Radiology · 199d
Cleared Sep 04, 2026
FCT iStream Phase 2
K253836 · JAK
Fujifilm Corporation
Radiology · 277d
Cleared Sep 02, 2026
Vivid Explorer/Vivid Advanced/Vivid Focus
K261313 · IYN
GE Medical Systems Ultrasound and...
Radiology · 134d