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 ×
15,589 results
2665–2688 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 26, 2020
DRX-Compass
K201373 · KPR
Carestream Health, Inc.
Radiology · 31d
Cleared Jun 26, 2020
ChartCheck
K201119 · IYE
Radformation, Inc.
Radiology · 60d
Cleared Jun 26, 2020
Rapid ASPECTS
K200760 · POK
Ischemaview, Inc.
Radiology · 94d
Cleared Jun 26, 2020
Optimized Positioning System (OPS) ReView
K193042 · LLZ
Corin USA
Radiology · 239d
Cleared Jun 24, 2020
ACUSON Sequoia Diagnostic Ultrasound System
K201462 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Jun 24, 2020
CINA
K200855 · QAS
Avicenna.Ai
Radiology · 85d
Cleared Jun 24, 2020
ControlRad Trace Model 9
K200663 · OWB
Controlrad, Inc.
Radiology · 103d
Cleared Jun 23, 2020
LVivo Software Application
K200232 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 145d
Cleared Jun 22, 2020
Axeos
K201140 · OAS
Dentsply Sirona
Radiology · 54d
Cleared Jun 19, 2020
AQUILA 320 D / AQUILA 320 S
K201340 · IZL
Vmi Tecnologias Ltda
Radiology · 30d
Cleared Jun 19, 2020
BriefCase
K193298 · QAS
Aidoc Medical , Ltd.
Radiology · 205d
Cleared Jun 18, 2020
Giotto Class (Models - 3000X-YY and 4000X-YY)
K200424 · MUE
Ims Giotto S.P.A.
Radiology · 119d
Cleared Jun 17, 2020
qER
K200921 · QAS
Qure.Ai Technologies
Radiology · 72d
Cleared Jun 17, 2020
AI-Rad Companion Brain MR
K193290 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 203d
Cleared Jun 15, 2020
Quantib AI Node
K200899 · LLZ
Quantib B.V.
Radiology · 73d
Cleared Jun 12, 2020
Kubtec Mozart Supra
K200756 · MWP
Kub Technologies, Inc.
Radiology · 80d
Cleared Jun 12, 2020
MAMMOMAT Revelation
K193166 · MUE
Siemens Medical Solutions USA, Inc.
Radiology · 210d
Cleared Jun 11, 2020
Gold Anchor
K201117 · IYE
Naslund Medical AB
Radiology · 45d
Cleared Jun 11, 2020
Versana Active
K200998 · IYN
GE Medical Systems Ultrasound and...
Radiology · 56d
Cleared Jun 11, 2020
Auto 3D Bladder Volume Tool
K200980 · IYO
Butterfly Network, Inc.
Radiology · 58d
Cleared Jun 11, 2020
MEDO ARIA
K200356 · QIH
Medo.Ai
Radiology · 119d
Cleared Jun 11, 2020
uWS-MI
K192630 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 262d
Cleared Jun 10, 2020
Intraoral Sensor
K201247 · MQB
Dentium Co., Ltd (Ict Branch)
Radiology · 30d
Cleared Jun 10, 2020
SR-8230, SR-8230S Portable X-ray Unit
K200976 · IZL
Shantou Institute of Ultrasonic...
Radiology · 58d