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
2665–2688 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 16, 2020
FibroScan® 630
K200655 · IYO
Echosens
Radiology · 126d
Cleared Jul 16, 2020
Vivid S60N, Vivid S70N
K200497 · IYN
GE Medical Systems Ultrasound and...
Radiology · 139d
Cleared Jul 14, 2020
Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit...
K193097 · LNH
Canon Medical Systems Corporation
Radiology · 250d
Cleared Jul 13, 2020
ExacTrac Dynamic
K201276 · IYE
Brainlab AG
Radiology · 61d
Cleared Jul 13, 2020
PROBEAT-CR
K201042 · LHN
Hitachi , Ltd.
Radiology · 84d
Cleared Jul 13, 2020
Digiscan FDX
K200218 · OWB
Allengers Medical Systems Limited
Radiology · 167d
Cleared Jul 10, 2020
DigitalDiagnost C50
K201725 · KPR
Philips Healthcare (Suzhou) Co., Lit.
Radiology · 17d
Cleared Jul 10, 2020
Eclipse Treatment Planning System v16.1
K201607 · MUJ
Varian Medical Systems, Inc.
Radiology · 25d
Cleared Jul 10, 2020
Resoundant Acoustic Driver System
K201389 · LNH
Resoundant, Inc.
Radiology · 44d
Cleared Jul 10, 2020
ASSISTO Universal Applicator Clamping Device
K201279 · JAQ
Geomed Medizin-Technik GmbH & Co. KG
Radiology · 58d
Cleared Jul 10, 2020
X-Cube 70
K200450 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 137d
Cleared Jul 10, 2020
X-Cube 90
K200449 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 137d
Cleared Jul 10, 2020
AI-Rad Companion Engine
K193294 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 226d
Cleared Jul 10, 2020
Ezra Plexo Software
K192969 · QIH
Ezra Ai, Inc.
Radiology · 261d
Cleared Jul 09, 2020
DuraDiagnost
K201640 · KPR
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 23d
Cleared Jul 09, 2020
XACT Robotic System
K201586 · JAK
Xact Robotics, Ltd.
Radiology · 28d
Cleared Jul 09, 2020
i-Rapha Solution
K201296 · LLZ
Irm, Inc.
Radiology · 55d
Cleared Jul 09, 2020
Rapid LVO
K200941 · QAS
Ischemaview, Inc.
Radiology · 92d
Cleared Jul 09, 2020
SR-8100 Portable X-ray Unit
K200637 · IZL
Shantou Institute of Ultrasonic...
Radiology · 121d
Cleared Jul 08, 2020
CMDR 2C (Multiple Models)
K201575 · IZL
Minxray, Inc.
Radiology · 27d
Cleared Jul 06, 2020
uMR570
K201540 · LNH
Shanghai United Imaging Healthcare...
Radiology · 27d
Cleared Jul 06, 2020
Lollipop BiteBlock
K200652 · IYE
Radtec Medical Devices, Inc.
Radiology · 116d
Cleared Jul 06, 2020
Deep Recon
K193073 · JAK
Shanghai United Imaging Healthcare...
Radiology · 245d
Cleared Jul 02, 2020
Terason uSmart 3200T Plus Ultrasound System
K201633 · IYN
Teratech Corporation
Radiology · 16d