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
4801–4824 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 19, 2014
S12 Digital Color Doppler Ultrasound System
K142474 · IYN
Sonoscape Company Limited
Radiology · 107d
Cleared Dec 18, 2014
Hermes Medical Imaging Suite v5.5
K142631 · KPS
Hermes Medical Solutions AB
Radiology · 92d
Cleared Dec 18, 2014
UniWeb 8.0
K142514 · LLZ
Ebm Technologies Incorporated
Radiology · 101d
Cleared Dec 18, 2014
MULTIX FUSION VA30 & VA40
K142049 · KPR
Siemens Medical Solutions USA, Inc.
Radiology · 143d
Cleared Dec 17, 2014
RTHawk, HeartVista Workstation with RTHawk
K142997 · LNH
Heartvista, Inc.
Radiology · 68d
Cleared Dec 17, 2014
HEPATIQ
K142891 · LLZ
Hepatiq, LLC
Radiology · 75d
Cleared Dec 17, 2014
Radlink GPS
K142718 · MQB
Radlink, Inc.
Radiology · 85d
Cleared Dec 17, 2014
GM60A-32S, GM60A-40S
K142492 · IZL
Samsung Electronics Co., Ltd.
Radiology · 104d
Cleared Dec 16, 2014
ArthroPlan Digital Templating Software
K142944 · LLZ
Arthromeda, Inc.
Radiology · 67d
Cleared Dec 16, 2014
EXA
K142919 · LLZ
Viztek, LLC
Radiology · 69d
Cleared Dec 16, 2014
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS
K142108 · MUJ
Brainlab AG
Radiology · 134d
Cleared Dec 16, 2014
ImmersiveTouch3 and MicrovisTouch
K140860 · LLZ
Immersivetouch
Radiology · 257d
Cleared Dec 15, 2014
BBS REVOLUTION
K142329 · IYO
Dbmedx, Inc.
Radiology · 117d
Cleared Dec 12, 2014
IPACS MEDICAL IMAGE MANAGEMENT SYSTEM
K140797 · LLZ
Visbion Limited
Radiology · 256d
Cleared Dec 11, 2014
Varian Head Frame
K142560 · IYE
Varian Medical Systems, Inc.
Radiology · 91d
Cleared Dec 10, 2014
eSie Apps Suite
K143254 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 27d
Cleared Dec 10, 2014
MD210C3 21.3 Diagnostic Imaging LCD Monitor
K142951 · PGY
Nec Display Solutions , Ltd.
Radiology · 61d
Cleared Dec 09, 2014
H60 V2.00 Diagnostic Ultrasound System
K143264 · IYN
Samsung Medison Co., Ltd.
Radiology · 26d
Cleared Dec 09, 2014
EP NAVIGATOR REL. 5.0
K142126 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 127d
Cleared Dec 05, 2014
Siemens 3.0T PROCURE Array Coil
K142676 · MOS
Resonance Innovations, LLC
Radiology · 77d
Cleared Dec 05, 2014
ONEFIT HIP PLANNER
K142671 · LLZ
Onefit Medical
Radiology · 77d
Cleared Dec 05, 2014
WaterProof PROFILER
K142431 · IYE
Sun Nuclear Corporation
Radiology · 98d
Cleared Dec 05, 2014
Discovery MR750 3.0T
K142361 · LNH
Ge Medical Systems, LLC
Radiology · 102d
Cleared Dec 05, 2014
QUALITY REPORTS
K142142 · IYE
Sun Nuclear Corporation
Radiology · 122d