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
457–480 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 12, 2025
PeekMed web
K252452 · QIH
Peek Health, S.A.
Radiology · 100d
Cleared Nov 10, 2025
EzSensor HD, EzSensor UHD
K252570 · MUH
Qpix Solutions, Inc.
Radiology · 88d
Cleared Nov 07, 2025
Fibresolve (with PCCP)
K252041 · QWO
Imvaria, Inc.
Radiology · 130d
Cleared Nov 07, 2025
Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER,...
K251853 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 143d
Cleared Nov 07, 2025
SugarBug (1.x)
K250264 · MYN
Bench7, Inc.
Radiology · 282d
Cleared Nov 06, 2025
BriefCase-Triage
K253265 · QAS
Aidoc Medical , Ltd.
Radiology · 38d
Cleared Nov 06, 2025
Adaptix Ortho350
K252133 · IZF
Adaptix Limited
Radiology · 122d
Cleared Nov 06, 2025
Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M)
K251004 · OXO
Hefei Chimed Intelligent Machine Co.,...
Radiology · 219d
Cleared Nov 04, 2025
VXvue
K251410 · LLZ
Vieworks Co., Ltd.
Radiology · 181d
Cleared Nov 04, 2025
Cios Select
K250241 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 281d
Cleared Nov 03, 2025
Sonosite MT Ultrasound System
K253448 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 32d
Cleared Nov 03, 2025
Acorn 3D Software (AC-SEG-4009)
K251532 · LLZ
Mighty Oak Medical
Radiology · 168d
Cleared Nov 03, 2025
ZAP-X Radiosurgery System (ZAP-X)
K250392 · IYE
Zap Surgical Systems, Inc.
Radiology · 264d
Cleared Nov 03, 2025
3mensio Workstation
K250330 · QIH
Pie Medical Imaging BV
Radiology · 271d
Cleared Oct 31, 2025
Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System
K252074 · IYN
Canon Medical Systems Corporation
Radiology · 121d
Not Cleared Oct 31, 2025
Pulsenmore ES
DEN240074 · SGJ
Pulsenmore, Ltd.
Radiology · 324d
Cleared Oct 30, 2025
AiORTA - Plan
K250337 · QIH
ViTAA Medical Solutions, Inc.
Radiology · 266d
Cleared Oct 29, 2025
LCD Monitor (C1216W, C822W, C821W)
K253242 · PGY
Shenzhen Beacon Display Technology...
Radiology · 30d
Cleared Oct 29, 2025
LOGIQ E10
K251985 · IYN
GE Medical Systems Ultrasound and...
Radiology · 124d
Cleared Oct 29, 2025
LOGIQ E10s
K251963 · IYN
GE Medical Systems Ultrasound and...
Radiology · 125d
Cleared Oct 28, 2025
TheraSphere 360™ Y-90 Management Platform
K252547 · LLZ
Boston Scientific Corporation
Radiology · 77d
Cleared Oct 27, 2025
cvi42 Coronary Plaque Software Application
K251027 · QIH
Circle Cardiovascular Imaging, Inc.
Radiology · 208d
Cleared Oct 24, 2025
Azurion R3.1
K251827 · OWB
Philips Medical Systems B.V.
Radiology · 133d
Cleared Oct 24, 2025
Mobile X-ray unit (!M1)
K251710 · IZL
Solutions For Tomorrow AB
Radiology · 143d