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
4609–4632 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 29, 2015
ECHELON Oval V 5.0 MRI System
K151015 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 104d
Cleared Jul 29, 2015
GenIQ
K143368 · LLZ
Ge Medical Systems, LLC
Radiology · 246d
Cleared Jul 28, 2015
3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display
K151854 · LLZ
D-View Display Technology Co., Ltd.
Radiology · 21d
Cleared Jul 28, 2015
Proton Immobilization Solution
K151207 · IYE
Orfit Industries NV
Radiology · 83d
Cleared Jul 28, 2015
QBit Series Diagnostic Ultrasound System
K150861 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 118d
Cleared Jul 24, 2015
EPX-Series Mobile X-ray System
K151038 · IZL
Ecotron Co., Ltd.
Radiology · 95d
Cleared Jul 23, 2015
E-CUBE 15 Diagnostic Ultrasound System
K150773 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 121d
Cleared Jul 23, 2015
iuStar300 Medical Ultrasound Diagnostic System
K141720 · IYN
United Imaging Systems (Beijing) Co.,...
Radiology · 393d
Cleared Jul 19, 2015
EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i
K151707 · MUH
Rayence Co., Ltd.
Radiology · 25d
Cleared Jul 17, 2015
Hi-Light Diagnostic Ultrasound Systems
K151709 · IYO
Qingdao Hisense Medical Equipment...
Radiology · 23d
Cleared Jul 17, 2015
GUA60A, GU60A-65
K151685 · KPR
Samsung Electronics Co., Ltd.
Radiology · 25d
Cleared Jul 17, 2015
Coronis Uniti
K151505 · PGY
Barco N.V.
Radiology · 43d
Cleared Jul 17, 2015
Biograph mCT and mCT Flow PET/CT Scanners
K151486 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 45d
Cleared Jul 17, 2015
3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set...
K150839 · JAQ
Varian Medical Systems, Inc.
Radiology · 109d
Cleared Jul 17, 2015
UltraLinq
K143176 · LLZ
Ultralinq Healthcare Solutions, Inc.
Radiology · 255d
Cleared Jul 13, 2015
Vitrea Software Toshiba Package, VSTP-001A
K151091 · LLZ
Toshibamedical Systems Corporation
Radiology · 81d
Cleared Jul 13, 2015
Aura DR 43C-AG flat panel detector
K151014 · MQB
Abyzr Co., Ltd.
Radiology · 88d
Cleared Jul 10, 2015
SIGNA Pioneer
K143345 · LNH
Ge Healthcare Japan Corporation
Radiology · 231d
Cleared Jul 09, 2015
Aplio 500/400/300 Diagnostic Ultrasound System V6.0
K151451 · IYN
Toshibamedical Systems Corporation
Radiology · 41d
Cleared Jul 09, 2015
Ablation Confirmation
K150313 · LLZ
Neuwave Medical, Inc.
Radiology · 150d
Cleared Jul 07, 2015
Dentrix Ascend Imaging
K151438 · LLZ
Realcloud Imaging, Inc.
Radiology · 39d
Cleared Jul 07, 2015
Monaco
K151233 · MUJ
Impac Medical Systems, Inc.
Radiology · 60d
Cleared Jul 01, 2015
CyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM System
K150873 · IYE
Accuray Incorporated
Radiology · 91d
Cleared Jun 30, 2015
GENESIS
K151485 · JAA
Dornier Medtech America, Inc.
Radiology · 28d