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
3481–3504 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 29, 2018
AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer...
K180572 · IYN
Supersonic Imagine
Radiology · 85d
Cleared May 24, 2018
CS 9600
K181136 · OAS
Trophy
Radiology · 24d
Cleared May 24, 2018
McKesson Cardiology
K181080 · LLZ
Change Healthcare Israel , Ltd.
Radiology · 30d
Cleared May 24, 2018
PIXX 1717
K180976 · MQB
Pixxgen Corporation
Radiology · 41d
Cleared May 24, 2018
Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound...
K180862 · IYN
Edan Instruments, Inc.
Radiology · 52d
Cleared May 24, 2018
GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85
K180543 · KPR
Samsung Electronics Co., Ltd.
Radiology · 84d
Not Cleared May 24, 2018
OsteoDetect
DEN180005 · QBS
Imagen Technologies, Inc.
Radiology · 108d
Cleared May 23, 2018
Biograph Vision
K180811 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 55d
Cleared May 22, 2018
NeuralBot
K180455 · IYN
Neural Analytics, Inc.
Radiology · 91d
Cleared May 21, 2018
MECALL CLISIS SYSTEMS, Discovery RF180
K173395 · JAA
General Medical Merate S.P.A
Radiology · 203d
Cleared May 18, 2018
Eclipse Treatment Planning System
K181145 · MUJ
Varian Medical Systems, Inc.
Radiology · 17d
Cleared May 18, 2018
LaVid FMTS DIAGNOSTIC X-RAY SYSTEM
K180663 · KPR
Livermoretech, Inc.
Radiology · 65d
Cleared May 16, 2018
Low Dose CT Lung Cancer Screening Option
K180901 · JAK
Hitachi Healthcare Americas
Radiology · 40d
Cleared May 16, 2018
Varian Cervical Sleeves
K172675 · JAQ
Varian Medical Systems, Inc.
Radiology · 253d
Cleared May 15, 2018
VIVIX-S 1717V
K181003 · MQB
Vieworks Co., Ltd.
Radiology · 29d
Cleared May 15, 2018
5D Viewer
K180883 · LLZ
Samsung Medison Co., Ltd.
Radiology · 41d
Cleared May 15, 2018
Astroid Planning App
K173940 · MUJ
.Decimal, LLC
Radiology · 140d
Cleared May 14, 2018
Clarius Ultrasound Scanner
K180799 · IYN
Clarius Mobile Health Corp.
Radiology · 48d
Cleared May 14, 2018
Ventripoint Medical System Plus (VMS+)
K173810 · IYN
Ventripoint Diagnostics , Ltd.
Radiology · 150d
Cleared May 14, 2018
Pristina Serena
K173576 · MUE
Ge Healthcare
Radiology · 175d
Cleared May 11, 2018
LineUp
K180727 · JAK
Curvebeam, LLC
Radiology · 52d
Cleared May 11, 2018
HS40 Diagnostic Ultrasound System
K180409 · IYN
Samsung Medison Co., Ltd.
Radiology · 86d
Cleared May 10, 2018
RadiForce MX194
K180961 · PGY
Eizo Corporation
Radiology · 28d
Cleared May 09, 2018
Halcyon
K181032 · IYE
Varian Medical Systems, Inc.
Radiology · 21d