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
1849–1872 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 12, 2022
Aquilion Precision (TSX-304A/4) V10.10 with AiCE
K220986 · JAK
Canon Medical Systems Corporation
Radiology · 161d
Cleared Sep 08, 2022
EFAI ChestSuite XR Pleural Effusion Assessment System
K222076 · QFM
Ever Fortune.Ai, Co., Ltd.
Radiology · 56d
Cleared Sep 07, 2022
syngo.via RT Image Suite
K220783 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 174d
Cleared Sep 06, 2022
Ez3D-i/E3
K222069 · LLZ
Ewoosoft Co., Ltd.
Radiology · 54d
Cleared Sep 06, 2022
LiverMultiScan v5 (LMSv5)
K213960 · LNH
Perspectum
Radiology · 263d
Cleared Sep 02, 2022
Omni Legend
K221932 · KPS
Ge Healthcare
Radiology · 63d
Cleared Sep 01, 2022
DrAid for Radiology v1
K221241 · QFM
Vinbrain Joint Stock Company
Radiology · 125d
Cleared Sep 01, 2022
Hybrid C70
K220579 · EHD
Digimed Co., Ltd.
Radiology · 192d
Cleared Aug 31, 2022
Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR
K222387 · LNH
Canon Medical Systems Corporation
Radiology · 23d
Cleared Aug 31, 2022
8ch Wrist Coil
K222325 · MOS
Invivo Corporation (Business Trade...
Radiology · 29d
Cleared Aug 31, 2022
Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20
K221955 · MUH
Realcloud Imaging Inc. Dba Realcloud...
Radiology · 57d
Cleared Aug 31, 2022
QT Scanner 2000 Model A
K220933 · IYO
Qt Imaging, Inc.
Radiology · 153d
Cleared Aug 30, 2022
Ultrasound Transmission Gels
K221999 · MUI
Hony Medical Co., Ltd.
Radiology · 54d
Cleared Aug 29, 2022
TCL3 Motion Tracking System
K221785 · LNH
Tracinnovations A/S
Radiology · 69d
Cleared Aug 29, 2022
Viz RV/LV
K221100 · QIH
Viz. Ai, Inc.
Radiology · 137d
Cleared Aug 26, 2022
BriefCase
K222277 · QAS
Aidoc Medical , Ltd.
Radiology · 28d
Cleared Aug 25, 2022
MRI Planner
K211841 · MUJ
Spectronic Medical AB
Radiology · 437d
Cleared Aug 24, 2022
AutoContour Model RADAC V2
K220598 · QKB
Radformation, Inc.
Radiology · 175d
Cleared Aug 23, 2022
FONA XDC
K222274 · EHD
Fona S.R.L
Radiology · 25d
Cleared Aug 23, 2022
1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
K222257 · MOS
Invivo Corporation (Business Trade...
Radiology · 27d
Cleared Aug 23, 2022
ClearCheck Model RADCC V2
K220583 · IYE
Radformation, Inc.
Radiology · 175d
Cleared Aug 22, 2022
HS40 Diagnostic Ultrasound System
K221599 · IYN
Samsung Medison Co., Ltd.
Radiology · 81d
Cleared Aug 22, 2022
ClearCalc Model RADCA V2
K220582 · MUJ
Radformation, Inc.
Radiology · 174d
Cleared Aug 19, 2022
MI View&GO
K222172 · QIH
Siemens Medical Solutions USA, Inc.
Radiology · 29d