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
1825–1848 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 30, 2022
uDR 380i Pro
K222339 · IZL
Shanghai United Imaging Healthcare...
Radiology · 58d
Cleared Sep 30, 2022
e-Ortho Shoulder Software v1.1
K220758 · LLZ
FH Industrie
Radiology · 199d
Cleared Sep 30, 2022
QIR Suite
K211611 · QIH
Casis Cardiac Simulation & Imaging...
Radiology · 493d
Cleared Sep 29, 2022
Digital Radiography CXDI-Elite, Digital Radiography E1
K222687 · MQB
Canon, Inc.
Radiology · 23d
Cleared Sep 29, 2022
GM85
K222353 · IZL
Samsung Electronics Co., Ltd.
Radiology · 56d
Cleared Sep 29, 2022
Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S,...
K221496 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 129d
Cleared Sep 29, 2022
Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S,...
K221300 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 147d
Cleared Sep 29, 2022
CogNet QmTRIAGE
K220080 · QFM
Medcognetics, Inc.
Radiology · 262d
Cleared Sep 28, 2022
BriefCase
K222329 · QAS
Aidoc Medical , Ltd.
Radiology · 57d
Cleared Sep 27, 2022
Digital Radiography CXDI-CS01
K222661 · MQB
Canon, Inc.
Radiology · 25d
Cleared Sep 27, 2022
5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound...
K222648 · IYN
Philips Ultrasound, LLC
Radiology · 26d
Cleared Sep 27, 2022
NS-HGlio
K221738 · QIH
Neosoma, Inc.
Radiology · 104d
Cleared Sep 27, 2022
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3
K220342 · OWB
Canon Medical Systems Corporation
Radiology · 232d
Cleared Sep 23, 2022
XACT Robotic System, ACE Model
K213759 · JAK
Xact Robotics, Ltd.
Radiology · 297d
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