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
4441–4464 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 12, 2016
Biograph Horizon PET/CT
K152880 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 104d
Cleared Jan 12, 2016
INFX-8000V, V6.20
K152696 · OWB
Toshibamedical Systems Corporation
Radiology · 113d
Cleared Jan 12, 2016
ImplantMax Software
K151152 · LLZ
Saturn Imaging, Inc.
Radiology · 257d
Cleared Jan 08, 2016
MRI Dynamic Analysis Plus
K153039 · LNH
Esaote, S.P.A.
Radiology · 81d
Cleared Jan 07, 2016
Volpara Imaging Software
K153427 · LLZ
Matakina Technology, Ltd.
Radiology · 43d
Cleared Jan 04, 2016
LOGIQ V1/ LOGIQ V2
K153037 · IYN
GE Medical Systems Ultrasound &...
Radiology · 77d
Cleared Jan 03, 2016
Ez3D Plus
K152746 · LLZ
Ewoosoft Co., Ltd.
Radiology · 102d
Cleared Dec 24, 2015
CareView 1800L
K153492 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 20d
Cleared Dec 24, 2015
MAGNETOM Amira
K152283 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Dec 24, 2015
Myray- HYPERION X5
K152162 · MUH
Cefla S.C.
Radiology · 143d
Cleared Dec 22, 2015
SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install...
K153369 · IYO
Volcano Corporation
Radiology · 29d
Cleared Dec 22, 2015
Philips Eleva Workspot with SkyFlow
K153318 · MQB
Philips Medical Systems Dmc GmbH
Radiology · 34d
Cleared Dec 22, 2015
MammoGRIP
K152038 · IZH
Women'S Imaging Solutions...
Radiology · 153d
Cleared Dec 22, 2015
Magnetic Reasonance Imaging System
K151074 · LNH
Jiangsu Magspin Instrument Co.,Ltd
Radiology · 244d
Cleared Dec 21, 2015
HM70A Diagnostic Ultrasound System
K153408 · IYN
Samsung Medison Co., Ltd.
Radiology · 26d
Cleared Dec 21, 2015
GR40CW
K153401 · MQB
Samsung Electronics Co., Ltd.
Radiology · 27d
Cleared Dec 21, 2015
Q Series Diagnostic Ultrasound System
K153085 · IYN
Chison Medical Imaging Co., Ltd.
Radiology · 56d
Cleared Dec 17, 2015
Intraluminal Applicator Set
K151022 · JAQ
Varian Medical Systems, Inc.
Radiology · 245d
Cleared Dec 16, 2015
ClearVue850 Diagnostic Ultrasound System
K153480 · IYN
Philips Health Care
Radiology · 14d
Cleared Dec 14, 2015
OTC12D AUTO RADIOGRAPHIC SYSTEM
K152767 · KPR
Del Medical, Inc.
Radiology · 81d
Cleared Dec 14, 2015
Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT...
K152554 · IYO
C.R. Bard, Inc.
Radiology · 97d
Cleared Dec 14, 2015
Econsole1
K152172 · LLZ
DRTECH Corporation
Radiology · 132d
Cleared Dec 14, 2015
QuickRay HD Intraoral Sensor
K151926 · MUH
Denterprise International, Inc.
Radiology · 153d
Cleared Dec 11, 2015
iViewDose R1.0
K153011 · IYE
Elekta Limited
Radiology · 58d