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
4369–4392 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 21, 2016
D-SPECT Processing and Reviewing Workstation
K160120 · KPS
Spectrum Dynamics , Ltd.
Radiology · 62d
Cleared Mar 18, 2016
FibroScan 530 Compact
K160524 · IYO
Echosens
Radiology · 22d
Cleared Mar 18, 2016
Tuxedo Digital Dental Sensor
K153710 · MQB
Led Dental, Inc.
Radiology · 85d
Cleared Mar 18, 2016
somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with...
K151749 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 263d
Cleared Mar 16, 2016
FUJIFILM FC1 Ultrasound System
K160406 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 29d
Cleared Mar 16, 2016
Vitrea CT Colon Analysis
K160150 · LLZ
Vital Images, Inc.
Radiology · 55d
Cleared Mar 16, 2016
Xeleris 4.0 Processing and Review Workstation
K153355 · LLZ
Ge Healthcare
Radiology · 117d
Cleared Mar 15, 2016
ArthrexVIP Web Portal
K153612 · LLZ
Custom Orthopaedic Solutions, Inc.
Radiology · 89d
Cleared Mar 14, 2016
Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital...
K153119 · KPR
Summit Industries, LLC
Radiology · 137d
Cleared Mar 11, 2016
CAAS Workstation
K151780 · IZI
Pie Medical Imaging BV
Radiology · 254d
Cleared Mar 10, 2016
ReadeR, VieweR, QuickScan PSP
K160386 · MUH
Trident S.R.L
Radiology · 28d
Cleared Mar 10, 2016
Vivid T8
K160078 · IYN
Ge Medical Systems Ultrasound and...
Radiology · 56d
Cleared Mar 09, 2016
TE7 Diagnostic Ultrasound System
K160381 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 28d
Cleared Mar 09, 2016
SmartView 3D Option
K153429 · JAK
Ge Hangwei Medical System Co., Ltd.
Radiology · 105d
Cleared Mar 08, 2016
TruGuard Custom Tongue and Jaw Positioner
K153270 · IYE
Bionix Development Corp.
Radiology · 117d
Cleared Mar 07, 2016
Cios Fusion
K153244 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 119d
Cleared Mar 04, 2016
syngo.via MI Workflows
K160426 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 17d
Cleared Mar 04, 2016
Platinum dRF Imaging System
K160301 · JAA
Apelem-Dms Group
Radiology · 29d
Cleared Mar 04, 2016
syngo Application Software VD11
K153346 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 105d
Cleared Mar 04, 2016
Sheathes Ultrasound Probe Covers
K153212 · ITX
Sheathing Technologies, Inc.
Radiology · 120d
Cleared Mar 03, 2016
Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21
K160347 · PGY
Qingdao Hisense Medical Equipment...
Radiology · 24d
Cleared Mar 03, 2016
Olea Sphere V3.0
K152602 · LLZ
Olea Medical
Radiology · 174d
Cleared Mar 01, 2016
Wrist 3
K160185 · LNH
Aspect Imaging, Ltd.
Radiology · 34d
Cleared Feb 29, 2016
syngo.via MI Workflows
K160317 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 24d