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
3505–3528 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 09, 2018
Navi e/Navi s/Navi X Diagnostic Ultrasound System
K180461 · IYN
Shenzhen Wisonic Medical Technology...
Radiology · 78d
Cleared May 09, 2018
Faxitron VisionCT
K173309 · MWP
Faxitron Bioptics, LLC
Radiology · 203d
Cleared May 04, 2018
Invenia ABUS Viewer
K180641 · LLZ
Ge Healthcare
Radiology · 53d
Cleared May 03, 2018
CAAS Workstation
K180019 · IZI
Pie Medical Imaging BV
Radiology · 121d
Cleared May 02, 2018
Venue
K180599 · IYN
GE Medical Systems Ultrasound and...
Radiology · 56d
Cleared Apr 30, 2018
ExactVu High Resolution Micro-Ultrasound System
K180636 · IYO
Exact Imaging, Inc.
Radiology · 49d
Cleared Apr 27, 2018
HDR MRI Lumen Marker
K180069 · JAQ
C4 Imaging, LLC
Radiology · 108d
Cleared Apr 27, 2018
hipEOS
K173390 · LLZ
Onefit Medical
Radiology · 179d
Cleared Apr 25, 2018
syngo.plaza
K180563 · LLZ
Siemens Healthcare GmbH
Radiology · 51d
Cleared Apr 25, 2018
VERITON NM
K180514 · KPS
Spectrum Dynamics Medical, Ltd.
Radiology · 57d
Cleared Apr 25, 2018
RayStation 7
K180379 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 72d
Cleared Apr 24, 2018
GSI Viewer with GSI Fat Option
K180225 · JAK
GE Medical Systems SCS
Radiology · 88d
Cleared Apr 24, 2018
ZOOM
K172768 · LLZ
Zetta Medical Technologies, LLC
Radiology · 223d
Cleared Apr 24, 2018
IMACTIS CT-Navigation system
K162314 · JAK
Imactis, Sas
Radiology · 614d
Cleared Apr 20, 2018
Aria
K180782 · KGI
GE Medical Systems Ultrasound &...
Radiology · 25d
Cleared Apr 20, 2018
Televere Podiatry X-Ray System HF
K180765 · KPR
Televere Systems, Inc.
Radiology · 28d
Cleared Apr 20, 2018
Viz CTP
K180161 · LLZ
Viz. Ai, Inc.
Radiology · 91d
Cleared Apr 20, 2018
Viamo c100 TUS-VC100 Diagnostic Ultrasound System
K173962 · IYN
Toshibamedical Systems Corporation
Radiology · 113d
Cleared Apr 19, 2018
syngo.MR Applications
K180336 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 71d
Cleared Apr 19, 2018
iSchemaView RAPID
K172477 · LLZ
Ischemaview, Inc.
Radiology · 246d
Cleared Apr 17, 2018
NM/CT 850, NM/CT 860
K173816 · KPS
Ge Healthcare
Radiology · 123d
Cleared Apr 13, 2018
SonoSite iViz Ultrasound System
K180704 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 25d
Cleared Apr 13, 2018
SmartGrid
K180667 · MQB
Carestream Health, Inc.
Radiology · 30d
Cleared Apr 13, 2018
U60 Diagnostic Ultrasound System
K180408 · IYN
Edan Instruments, Inc.
Radiology · 58d