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
1417–1440 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 22, 2023
qXR-CTR
K231149 · QIH
Qure.Ai Technologies
Radiology · 154d
Cleared Sep 22, 2023
Jazz
K223659 · LLZ
Ai Medical AG
Radiology · 290d
Cleared Sep 21, 2023
CAREMIBRAIN
K232569 · KPS
General Equipment For Medical...
Radiology · 28d
Cleared Sep 21, 2023
Overjet Periapical Radiolucency Assist
K231678 · MYN
Overjet, Inc.
Radiology · 104d
Cleared Sep 20, 2023
Rology Teleradiology Platform (v.1.22.1103)
K231385 · LLZ
Rology, Inc.
Radiology · 131d
Cleared Sep 19, 2023
GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series)
K232178 · KPR
DRGEM Corporation
Radiology · 57d
Cleared Sep 19, 2023
Aquilion Serve (TSX-307A/1) V1.3
K231281 · JAK
Canon Medical Systems Corporation
Radiology · 139d
Cleared Sep 15, 2023
Carnation series Diagnostic Ultrasound System
K230066 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 249d
Cleared Sep 14, 2023
Provecta 3D Prime and Provecta 3D Prime Ceph
K232487 · OAS
Durr Dental SE
Radiology · 28d
Cleared Sep 14, 2023
ThermPix Thermovisual Camera
K232462 · LHQ
Usa Therm, Inc.
Radiology · 30d
Cleared Sep 14, 2023
OrionXR
K232189 · LLZ
Hoth Intelligence, Inc.
Radiology · 52d
Cleared Sep 14, 2023
cNeuro cPET
K231576 · KPS
Combinostics OY
Radiology · 106d
Cleared Sep 14, 2023
AccuCTP Pro
K231353 · LLZ
ArteryFlow Technology Co., Ltd.
Radiology · 127d
Cleared Sep 14, 2023
NEUROShield
K220034 · LLZ
In-Med Prognostics L3c
Radiology · 617d
Cleared Sep 13, 2023
GenX-CR
K232158 · MUH
Genoray Co., Ltd.
Radiology · 55d
Cleared Sep 13, 2023
Lung-CAD
K223811 · MYN
Imagen Technologies, Inc.
Radiology · 267d
Cleared Sep 12, 2023
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
K232526 · JAA
Canon Medical Systems Corporation
Radiology · 22d
Cleared Sep 12, 2023
Velacur
K232459 · IYO
Sonic Incytes
Radiology · 28d
Cleared Sep 12, 2023
Definium Pace Select
K231892 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 76d
Cleared Sep 12, 2023
Cartesion Prime (PCD-1000A/3) V10.15
K231748 · KPS
Canon Medical Systems Corporation
Radiology · 89d
Cleared Sep 12, 2023
TrueBeam, TrueBeam STx, Edge, VitalBeam
K231317 · IYE
Varian Medical Systems, Inc.
Radiology · 127d
Cleared Sep 12, 2023
Ablation-fit
K222938 · QTZ
R.A.W. S.R.L
Radiology · 351d
Cleared Sep 11, 2023
SiteRite™ 9 Ultrasound System
K231283 · IYO
Bard Access Systems, Inc. (C.R. Bard,...
Radiology · 131d
Cleared Sep 08, 2023
VariSeed (v10)
K232400 · MUJ
Varian Medical Systems
Radiology · 29d