FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,570 results
361–384 of 15,570
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
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
Cleared Oct 24, 2025
Syngo Carbon Clinicals (VA41)
K251059 · QIH
Siemens Healthineers AG
Radiology · 203d
Cleared Oct 24, 2025
AccuCheck
K250696 · IYE
Manteia Technologies Co., Ltd.
Radiology · 231d
Cleared Oct 24, 2025
Cocoon Solo (DX-7020s)
K250687 · MUH
Dexcowin Global, Inc.
Radiology · 232d
Cleared Oct 23, 2025
TeraRecon Cardiovascular.Calcification.CT
K250288 · QIH
Terarecon,Inc.
Radiology · 265d
Cleared Oct 22, 2025
ANDI 2.0
K252298 · QIH
Imeka Solutions, Inc.
Radiology · 91d
Cleared Oct 22, 2025
Sirona Advanced Imaging Suite
K251030 · LLZ
Sirona Medical
Radiology · 202d
Cleared Oct 20, 2025
InkSpace Imaging Small Body Array (SBA12PH30x)
K253182 · MOS
Inkspace Imaging, Inc.
Radiology · 24d
Cleared Oct 20, 2025
brAIn™ Shoulder Positioning
K252665 · QIH
Avatar Medical
Radiology · 56d
Cleared Oct 17, 2025
X1-FFR
K251355 · QHA
Spectrawave, Inc.
Radiology · 170d
Cleared Oct 17, 2025
MOSkin Radiation Measurement System
K250911 · IYE
Electrogenics Labs, Ltd.
Radiology · 205d
Cleared Oct 16, 2025
Viewer (5.4)
K252476 · LLZ
Brainlab AG
Radiology · 70d
Cleared Oct 15, 2025
AGFA HealthCare Enterprise Imaging
K252199 · LLZ
Agfa Healthcare N.V.
Radiology · 93d