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
1825–1848 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 14, 2022
AI-Rad Companion Organs RT
K221305 · QKB
Siemens Medical Solutions USA, Inc.
Radiology · 162d
Cleared Oct 14, 2022
X-CUBE 70, X-CUBE 90
K221093 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 184d
Cleared Oct 13, 2022
X-CUBE 50, X-CUBE 60
K220857 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 204d
Cleared Oct 13, 2022
Wireless Probe Type Ultrasound Scanner (Model: CProbe
K211321 · IYN
Guangzhou Sonostar Technologies Co.,...
Radiology · 531d
Cleared Oct 11, 2022
SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L,...
K220169 · IYN
Bionet Co., Ltd.
Radiology · 264d
Cleared Oct 07, 2022
BriefCase
K220709 · QAS
Aidoc Medical , Ltd.
Radiology · 211d
Cleared Oct 07, 2022
MIM-Ablation
K220256 · QTZ
Mim Software, Inc.
Radiology · 249d
Cleared Oct 06, 2022
Garion Image-Intensified Fluoroscopic X-Ray System, Mobile
K222080 · OWB
Sg Healthcare Co, Ltd.
Radiology · 83d
Cleared Oct 06, 2022
Genius AI Detection 2.0
K221449 · QDQ
Hologic, Inc.
Radiology · 141d
Cleared Sep 30, 2022
Shield System
K222625 · OWB
Radiaction , Ltd.
Radiology · 30d
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