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
6481–6504 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 16, 2010
SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION)
K092427 · LLZ
Albert Davydov Dds PC Professional
Radiology · 221d
Cleared Mar 16, 2010
OASIS MRI SYSTEM
K093044 · LNI
Hitachi Medical Systems America, Inc.
Radiology · 167d
Cleared Mar 16, 2010
I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5
K093066 · OWB
Infimed, Inc.
Radiology · 167d
Cleared Mar 16, 2010
VESISCAN
K093485 · IYO
Life-Tech, Inc.
Radiology · 127d
Cleared Mar 12, 2010
SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY...
K092922 · IYN
Sonoscape Company Limited
Radiology · 170d
Cleared Mar 12, 2010
RAYSTATION VERSION 1.0
K100552 · MUJ
Raysearch Laboratories AB
Radiology · 14d
Cleared Mar 11, 2010
IGUIDE CAPPA
K093787 · JAK
Cas Innovations GmbH & Co. KG
Radiology · 92d
Cleared Mar 11, 2010
CARESTREAM IMAGE SUITE
K100094 · LLZ
Carestream Heatlh, Inc.
Radiology · 57d
Cleared Mar 11, 2010
DIAGNOSOFT HARP MODEL 2.06
K100352 · LNH
Diagnosoft, Inc.
Radiology · 27d
Cleared Mar 10, 2010
XVI R4.5
K100115 · IYE
Elekta , Ltd.
Radiology · 54d
Cleared Mar 05, 2010
STEREOS WORKSTATION
K090050 · LLZ
Biospace Med
Radiology · 422d
Cleared Mar 05, 2010
P-ART, MODEL 001
K092424 · IYE
P-Cure, Ltd.
Radiology · 210d
Cleared Mar 05, 2010
DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY...
K092907 · IYN
Shantou Institute of Ultrasonic...
Radiology · 164d
Cleared Mar 05, 2010
INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM
K093336 · LNH
Medical Numerics, Inc.
Radiology · 130d
Cleared Mar 05, 2010
CUATTRO UNOMD
K093480 · LLZ
Cuattro, LLC
Radiology · 116d
Cleared Mar 05, 2010
1.5T AND 3.0T GENERAL PURPOSE FLEX COILS
K093842 · MOS
Invivo Corporation
Radiology · 80d
Cleared Mar 05, 2010
SITE-RITE VISION ULTRASOUND SYSTEM
K100402 · IYN
Bard Access Systems, Inc.
Radiology · 17d
Cleared Mar 04, 2010
SYNGO.PLAZA
K093612 · LLZ
Siemens AG Medical Solutions
Radiology · 101d
Cleared Mar 03, 2010
COLOR LCD MONITOR, MODEL RADIFORCE RS210
K092613 · LLZ
Eizo Nanao Corporation
Radiology · 189d
Cleared Mar 03, 2010
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K093812 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Mar 03, 2010
ZEISS INFRARED 800 WITH FLOW 800 OPTION
K100468 · IZI
Carl Zeiss Surgical GmbH
Radiology · 13d
Cleared Mar 01, 2010
ECHOPLAQUE
K092842 · LLZ
Indec Systems, Inc.
Radiology · 167d
Cleared Mar 01, 2010
DIGITAL ULTRASOUND SCANNER
K100079 · IYO
Shenzhen Well.D Medical Electronics...
Radiology · 48d
Cleared Feb 24, 2010
FLEXIMARC, MODEL CM-0.9-2-10-GG-L
K100267 · IYE
Cortex Manufacturing, Inc.
Radiology · 26d