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
7657–7680 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jul 28, 2006
IBA PROTON THERAPY SYSTEM - PROTEUS 235
K061913 · LHN
Ion Beam Applications S.A.
Radiology · 22d
Cleared Jul 28, 2006
INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY
K061930 · LNH
Fonar Corp.
Radiology · 21d
Cleared Jul 28, 2006
CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND...
K061952 · MOS
Invivo
Radiology · 18d
Cleared Jul 27, 2006
TOPSLANE DMLC
K060187 · IXI
Topslane International, LLC
Radiology · 184d
Cleared Jul 27, 2006
ECHO VIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1200PRO
K061643 · IYN
Shimadzu Medical Systems
Radiology · 45d
Cleared Jul 27, 2006
SYNGO MULTIMODALITY WORKPLACE
K061964 · LLZ
Siemens AG Medical Solutions
Radiology · 15d
Cleared Jul 25, 2006
ERAD PACS
K061421 · LLZ
Erad, Inc.
Radiology · 64d
Cleared Jul 25, 2006
DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA
K061429 · LNH
Esaote, S.P.A.
Radiology · 63d
Cleared Jul 25, 2006
SYNGO EXPERT-1
K061449 · JAK
Siemens Medical Solution
Radiology · 61d
Cleared Jul 25, 2006
VARISOURCE 200 HDR AFTERLOADER
K061582 · JAQ
Varian Medical Systems, Inc.
Radiology · 48d
Cleared Jul 25, 2006
ECHOVIEW/ SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-2200PRO
K061637 · IYN
Shimadzu Medical Systems
Radiology · 43d
Cleared Jul 25, 2006
INTEGRA RADIONICS XKNIFE RT 4
K061893 · MUJ
Integra Radionics, Inc.
Radiology · 22d