FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
7489–7512 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Aug 18, 2006
SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003
K062107 · LLZ
Hologic, Inc.
Radiology · 25d
Cleared Aug 18, 2006
HD11 DIAGNOSTIC ULTRASOUND SYSTEM
K062247 · IYN
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Aug 17, 2006
MICROSELECTRON V3, MODEL 106.990
K061354 · JAQ
Nucletron Corporation
Radiology · 94d
Cleared Aug 17, 2006
XAMINER
K061595 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 70d
Cleared Aug 17, 2006
SIEMENS ACUSON X500 ULTRASOUND SYSTEM
K061980 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 35d
Cleared Aug 17, 2006
CXDI-40EC
K062221 · MQB
Canon, Inc.
Radiology · 15d
Cleared Aug 15, 2006
FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50
K061361 · MWP
Faxitron X-Ray Corp.
Radiology · 91d
Cleared Aug 15, 2006
9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS
K061953 · OWB
Ge Oec Medical Systems
Radiology · 36d
Cleared Aug 15, 2006
DRY LASER IMAGER, DRYPRO MODEL 832
K061999 · LMC
Konica Minolta Medical & Graphic, Inc.
Radiology · 32d
Cleared Aug 11, 2006
NEURO II-SE, MODELS OR-MB-DR AND OR-DR
K061916 · LNH
Imris, Inc.
Radiology · 36d
Cleared Aug 10, 2006
VOLCANO S51 FAMILY OF IMAGING SYSTEMS
K061215 · IYO
Volcano Corporation
Radiology · 100d
Cleared Aug 10, 2006
NEUROQUANT
K061855 · LLZ
Cortechs Labs, Inc.
Radiology · 41d
Cleared Aug 10, 2006
VITAL CONNECT 4.0
K062154 · LLZ
Vital Images, Inc.
Radiology · 13d
Cleared Aug 07, 2006
MYLAB15/20 NEW INDICATIONS ULTRASOUND SYSTEM
K061755 · IYO
Esaote Europe B.V.
Radiology · 47d
Cleared Aug 07, 2006
MEDCHANNEL HTS SYSTEM
K061831 · IYN
Medchannel, LLC
Radiology · 40d
Cleared Aug 07, 2006
XCAT
K061834 · JAK
Xoran Technologies, Inc.
Radiology · 39d
Cleared Aug 07, 2006
MONOCHROME LCD MONITOR, RADIFORCE, GS320
K062053 · LLZ
Eizo Nanao Corporation
Radiology · 18d
Cleared Aug 04, 2006
BEST STRAND AND BEST SPACER
K061638 · KXK
Best Medical International, Inc.
Radiology · 53d
Cleared Aug 04, 2006
SONIX ULTRASOUND SCANNER
K061827 · IYN
Ultrasonix Medical Corporation
Radiology · 37d
Cleared Jul 28, 2006
CALYPSO 4D LOCALIZATION SYSTEM
K060906 · IYE
Calypso Medical Technologies, Inc.
Radiology · 116d
Cleared Jul 28, 2006
BIOLUCENT APPLICATOR, MODEL RTA-XX
K061241 · JAQ
Biolucent, Inc.
Radiology · 86d
Cleared Jul 28, 2006
DIAGNOSOFT HARP
K061368 · LNH
Diagnosoft, Inc.
Radiology · 73d
Cleared Jul 28, 2006
HIP STRUCTURAL ANALYSIS SOFTWARE OPTION FOR THE HOLOGIC QDR X-RAY BONE...
K061561 · KGI
Hologic, Inc.
Radiology · 53d
Cleared Jul 28, 2006
MRGFUS GENERAL PURPOSE AND BREAST COIL
K061715 · MOS
Insightec Txsonics, Inc.
Radiology · 39d