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
3457–3480 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 22, 2018
Shear Wave Quantificational Ultrasound Diagnostic System
K173595 · IYO
Wuxi Hisky Medical Technologies Co.,...
Radiology · 213d
Cleared Jun 21, 2018
Eclipse II
K180809 · MQB
Carestream Health, Inc.
Radiology · 85d
Cleared Jun 20, 2018
Televere Digital Dental Imaging System
K181358 · MUH
Televere Systems, Inc.
Radiology · 29d
Cleared Jun 20, 2018
Visura Technologies TEECAD System
K180911 · FDS
Visura Technologies, LLC
Radiology · 75d
Cleared Jun 19, 2018
sterEOS Workstation
K172346 · LLZ
Eos Imaging
Radiology · 320d
Cleared Jun 15, 2018
Fusion Bx 2.0
K181290 · LLZ
Focal Healthcare, Inc.
Radiology · 30d
Cleared Jun 15, 2018
Prodiva 1.5T CX and Prodiva 1.5T CS R5.4
K173507 · LNH
Philips Healthcare (Suzhou) Co., Ltd.
Radiology · 214d
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