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
1849–1872 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 20, 2022
Aorta-CAD
K213353 · MYN
Imagen Technologies, Inc.
Radiology · 347d
Cleared Sep 19, 2022
C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD...
K222121 · PGY
Nanjing Jusha Display Technology Co.,...
Radiology · 63d
Cleared Sep 15, 2022
P12 Elite Series Digital Color Doppler Ultrasound System
K221089 · IYN
Sonoscape Medical Corp.
Radiology · 155d
Cleared Sep 14, 2022
BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes...
K221797 · JAQ
Varian Medical Systems, Inc.
Radiology · 85d
Cleared Sep 13, 2022
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit
K221733 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 90d
Cleared Sep 13, 2022
CLAROX plus (Model: VX-100)
K221417 · IZL
Vsi Co., Ltd.
Radiology · 120d
Cleared Sep 13, 2022
P20 Elite Series Digital Color Doppler Ultrasound System
K221140 · IYN
Sonoscape Medical Corp.
Radiology · 147d
Cleared Sep 13, 2022
Solid State X-ray Imager(Model: FXRD-4386WB)
K220239 · MQB
Vieworks Co., Ltd.
Radiology · 228d
Cleared Sep 12, 2022
KOLO Evolution XHD Series Ultrasound Diagnostic System
K221568 · IYN
Kolo Medical (Suzhou) Co., Ltd.
Radiology · 104d
Cleared Sep 12, 2022
Rapid ICH
K221456 · QAS
Ischemaview, Inc.
Radiology · 116d
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