FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
3433–3456 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 14, 2018
MRIaudio PREM System
K180100 · LNH
Mriaudio
Radiology · 149d
Cleared Jun 14, 2018
EchoMD Automated Ejection Fraction Software
K173780 · LLZ
Bay Labs, Inc.
Radiology · 184d
Cleared Jun 13, 2018
EcoVue Sterile and Non-Sterile Ultrasound Gels
K181363 · MUI
H R Pharmaceuticals, Inc.
Radiology · 21d
Cleared Jun 13, 2018
Ysio Max
K181279 · KPR
Siemens Medi Cal Solutions, Inc.
Radiology · 29d
Cleared Jun 13, 2018
PEDRA-17F Digital Flat Panel X-ray Detector
K180989 · MQB
Radisen, Inc.
Radiology · 58d
Cleared Jun 13, 2018
HealthCCS
K172983 · JAK
Zebra Medical Vision, Ltd.
Radiology · 259d
Cleared Jun 12, 2018
HeartSee Cardiac P.E.T. Processing Software
K181343 · KPS
Bracco Diagnostics, Inc.
Radiology · 22d
Cleared Jun 12, 2018
SyMRI
K181093 · LNH
Syntheticmr AB
Radiology · 48d
Cleared Jun 11, 2018
LIAC HWL
K172961 · IYE
Sit Sordina Iort Technologies Spa
Radiology · 258d
Cleared Jun 08, 2018
17HK700G-W
K180332 · MQB
Lg Electronics
Radiology · 122d
Cleared Jun 07, 2018
QLAB Advanced Quantification Software
K181264 · LLZ
Philips Ultrasound, Inc.
Radiology · 24d
Cleared Jun 07, 2018
Orthopantomograph OP 3D
K180947 · OAS
Palodex Group OY
Radiology · 57d
Cleared Jun 06, 2018
uMR 560
K180926 · LNH
Shanghai United Imaging Healthcare...
Radiology · 58d
Cleared Jun 06, 2018
uMR 570
K180925 · LNH
Shanghai United Imaging Healthcare...
Radiology · 58d
Cleared Jun 05, 2018
LungQ Software
K173821 · JAK
Thirona Corporation
Radiology · 169d
Cleared May 31, 2018
Interventional Workspot
K181177 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 29d
Cleared May 31, 2018
ACUSON SC2000 Diagnostic Ultrasound System
K181098 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 35d
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