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
3745–3768 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 26, 2017
OrthoVision
K173094 · LLZ
Ewoosoft Co., Ltd.
Radiology · 27d
Cleared Oct 26, 2017
Cocoon Portable Handheld X-Ray System
K173046 · MUH
Dexcowin Co., Ltd.
Radiology · 28d
Cleared Oct 25, 2017
M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound
K172970 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 29d
Cleared Oct 25, 2017
CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software...
K172455 · IYO
Volcano Corporation
Radiology · 72d
Cleared Oct 25, 2017
SunCHECK
K170307 · IYE
Sun Nuclear Corporation
Radiology · 266d
Cleared Oct 25, 2017
Advance Medical Designs, Inc. Sterile Ultrasound Gel
K163050 · MUI
Advance Medical Designs, Inc.
Radiology · 358d
Cleared Oct 24, 2017
Nexus DR Digital X-ray Imaging System (with PaxScan 4343RC and PaxScan 4343Rv3)
K172951 · MQB
Varex Imaging Corporation
Radiology · 28d
Cleared Oct 24, 2017
Dynamic Coronary Roadmap 2.0
K172307 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 85d
Cleared Oct 20, 2017
Discovery XR656 HD
K172869 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 30d
Cleared Oct 20, 2017
Adani MammoScan
K172027 · MUE
Adani
Radiology · 107d
Cleared Oct 20, 2017
BR-FHUS Viewer 1.0
K171709 · LLZ
Taihao Medical, Inc.
Radiology · 134d
Cleared Oct 20, 2017
Accuro
K171594 · IYO
Rivanna Medical, LLC
Radiology · 142d
Cleared Oct 20, 2017
Quantra
K163623 · LLZ
Hologic, Inc.
Radiology · 302d
Cleared Oct 20, 2017
OCTAVIUS I, OCTAVIUS II, OCTAVIUS III, OCTAVIUS 4D
K160405 · IYE
Ptw-Freiburg...
Radiology · 612d
Cleared Oct 18, 2017
Curve Image 2.0 PACS
K173101 · LLZ
Curve Dental, Ltd.
Radiology · 19d
Cleared Oct 18, 2017
M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System
K171579 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 140d
Cleared Oct 18, 2017
OrthoView 7.2
K171068 · LLZ
Meridian Technique, Ltd.
Radiology · 191d
Cleared Oct 13, 2017
DX-D Imaging Package
K172784 · MQB
Agfa Healthcare N.V.
Radiology · 28d
Cleared Oct 13, 2017
Galaxy R Digital Radiography Upgrade
K172435 · MQB
Medien International Co, Ltd.
Radiology · 63d
Cleared Oct 12, 2017
SKR 3000
K172793 · MQB
Konica Minolta, Inc.
Radiology · 27d
Cleared Oct 12, 2017
Aquarius 8600 1417TG and Aquarius 8600 1717TG
K171169 · MQB
Imaging Dynamics Company , Ltd.
Radiology · 174d
Cleared Oct 12, 2017
MAGNETOM Terra
K170840 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 205d
Cleared Oct 12, 2017
SONON Ultrasound Imaging System, Model: 300L
K170085 · IYN
Healcerion Co., Ltd.
Radiology · 275d
Cleared Oct 06, 2017
Edge Digital Flat Panel X-ray Detector
K172682 · MQB
Osko, Inc.
Radiology · 30d