FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
2689–2712 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 02, 2020
2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+
K201599 · PGY
Shenzhen Beacon Display Technology...
Radiology · 20d
Cleared Jul 02, 2020
Contour ProtegeAI
K193252 · QKB
Mim Software, Inc.
Radiology · 220d
Cleared Jul 02, 2020
InferRead Lung CT.AI
K192880 · OEB
Beijing Infervision Technology Co., Ltd.
Radiology · 267d
Cleared Jul 01, 2020
syngo.via View&GO
K201477 · LLZ
Siemens Healthcare GmbH
Radiology · 28d
Cleared Jul 01, 2020
Versana Premier
K200138 · IYN
Ge Medical Systems Ultrasound And
Radiology · 162d
Cleared Jun 29, 2020
Edge Air(1417) Digital Flat Panel X-ray Detector
K201503 · MQB
Osko, Inc.
Radiology · 24d
Cleared Jun 29, 2020
ARTIS pheno (VE2)
K201156 · OWB
Siemens Medical Solution USA, Inc.
Radiology · 60d
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