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
3889–3912 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 08, 2017
Vitrea Software Toshiba Package
K171222 · LLZ
Toshibamedical Systems Corporation
Radiology · 43d
Cleared Jun 08, 2017
Accuray Precision Treatment Planning System
K171086 · IYE
Accuray Incorporated
Radiology · 57d
Cleared Jun 08, 2017
Intraskan DC Plus
K170967 · EHD
Skanray Technologies Private Limited
Radiology · 69d
Cleared Jun 07, 2017
CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris
K171353 · IZL
Minxray, Inc.
Radiology · 29d
Cleared Jun 07, 2017
MRIdian Linac System with 138-leaf Collimator
K170751 · IYE
Viewray, Incorporated
Radiology · 86d
Cleared Jun 07, 2017
Vantage Titan 1.5T, MRT-1510, M-Power GX
K170412 · LNH
Toshibamedical Systems Corporation
Radiology · 117d
Cleared Jun 07, 2017
SmartTarget
K170250 · LLZ
Smarttarget, Ltd.
Radiology · 131d
Cleared Jun 07, 2017
StentBoost Live
K170144 · OWB
Philips Medical Stystems Nederland BV
Radiology · 141d
Cleared Jun 06, 2017
SonoBook Series Diagnostic Ultrasound System
K170374 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 119d
Cleared Jun 06, 2017
QT Ultrasound Breast Scanner-1
K162372 · IYO
Qt Ultrasound, LLC
Radiology · 286d
Cleared Jun 05, 2017
Revolution ACT
K171013 · JAK
Ge Hangwei Medical Systems Co., Ltd.
Radiology · 62d
Cleared Jun 02, 2017
Dynamic Coronary Roadmap
K170130 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 140d
Cleared Jun 01, 2017
syngo Dynamics Version VA30
K171053 · LLZ
Siemens Healthcare GmbH
Radiology · 52d
Cleared Jun 01, 2017
Biograph Horizon PET/CT
K170904 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Jun 01, 2017
GTK Disposable Needle Guides
K170741 · ITX
Geotek Medikal Ltd Sti
Radiology · 83d
Cleared Jun 01, 2017
Celesteion, PCA-9000A/3
K170490 · KPS
Toshibamedical Systems Corporation
Radiology · 104d
Cleared Jun 01, 2017
System, Applicator, Radionuclide, Remote Controlled
K170203 · JAQ
Kobold, LLC
Radiology · 129d
Cleared Jun 01, 2017
OARtrac System with Patient Specific Reusable Universal PSD Sensors
K162954 · NZT
Radiadyne, LLC
Radiology · 220d
Cleared May 30, 2017
QLAB Advanced Quantification Software
K171314 · LLZ
Philips Health Care
Radiology · 26d
Cleared May 30, 2017
TRINITY/3D PROSTATE SUITE
K170521 · IYN
Koelis
Radiology · 97d
Cleared May 30, 2017
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1
K163702 · IYN
Toshibamedical Systems Corporation
Radiology · 152d
Cleared May 30, 2017
ARIETTA PRECISION
K163505 · IYN
Hitachi , Ltd.
Radiology · 167d
Cleared May 30, 2017
AmCAD-US
K162574 · LLZ
Amcad Biomed Corporation
Radiology · 257d
Cleared May 26, 2017
DELL UP3017 with QUBYX PerfectLum bundle
K171229 · PGY
Qubyx Software Technologies, Inc.
Radiology · 29d