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
3721–3744 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 14, 2017
Biograph mMR with mMR Angio Transfer Option
K172531 · OUO
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Nov 14, 2017
Planmeca Romexis
K171385 · LLZ
Planmeca Oy
Radiology · 187d
Cleared Nov 14, 2017
Dolphin/IQ and Dolphin/4D
K170859 · IYN
Viasonix , Ltd.
Radiology · 237d
Cleared Nov 09, 2017
Aquarius 8600 1417WCI
K173273 · MQB
Imaging Dynamics Company , Ltd.
Radiology · 28d
Cleared Nov 09, 2017
OEC One
K172700 · OWB
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 63d
Cleared Nov 09, 2017
Televere Podiatry Digital Imaging System
K172124 · MQB
Televere Systems
Radiology · 118d
Cleared Nov 09, 2017
Philips CT Big Bore
K171850 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 141d
Cleared Nov 09, 2017
BioZorb Marker GOLD / LP Marker GOLD
K171467 · IYE
Focal Therapeutics
Radiology · 175d
Cleared Nov 08, 2017
Surgical Planning Software version 1.1
K173247 · LLZ
Ortho Kinematics, Inc.
Radiology · 33d
Cleared Nov 08, 2017
RadiForce RX560, RX560-AR
K172738 · PGY
Eizo Corporation
Radiology · 57d
Cleared Nov 07, 2017
UltraVision 2 Diagnostic Ultrasound System
K173265 · IYN
Winprobe Corporation
Radiology · 27d
Cleared Nov 03, 2017
CSMC Cardiac Suite
K172609 · KPS
Cedars-Sinai Medical Center
Radiology · 64d
Cleared Nov 02, 2017
Vivid E80, Vivid E90, Vivid E95
K173341 · IYN
GE Medical Systems
Radiology · 9d
Cleared Oct 31, 2017
ALOKA ARIETTA 850
K171708 · IYN
Hitachi Healthcare Americas Corporation
Radiology · 145d
Cleared Oct 30, 2017
XIDF-AWS801, Angio Workstation, V7.0
K172646 · OWB
Toshibamedical Systems Corporation
Radiology · 59d
Cleared Oct 30, 2017
SenoBright HD
K172404 · MUE
Ge Healthcare
Radiology · 82d
Cleared Oct 27, 2017
Biim Diagnostic Ultrasound System
K173138 · IYO
Biim Ultrasound AS
Radiology · 28d
Cleared Oct 27, 2017
ASPIRE Cristalle
K173132 · MUE
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 28d
Cleared Oct 27, 2017
2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)
K172815 · PGY
Shenzhen Beacon Display Technology...
Radiology · 39d
Cleared Oct 27, 2017
Infinitt PACS 7.0
K172803 · LLZ
Infinitt Healthcare Co., Ltd.
Radiology · 39d
Cleared Oct 27, 2017
LINACwatch, LinacView
K172534 · IYE
Qualiformed Sarl
Radiology · 66d
Cleared Oct 27, 2017
SANGRAY
K172087 · MOT
Hitachi , Ltd.
Radiology · 108d
Cleared Oct 27, 2017
C5 Diagnostic Ultrasound System
K171926 · IYN
Guangzhou Sonostar Technologies Co.,...
Radiology · 122d
Cleared Oct 27, 2017
SOFTDISO
K170345 · IYE
Best Nomos
Radiology · 266d