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
7057–7080 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 04, 2008
NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE
K081426 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 14d
Cleared Jun 03, 2008
SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
K080555 · ITX
Ivu Imaging Corporation
Radiology · 96d
Cleared Jun 02, 2008
SOMATOM DEFINITION, MODEL AS/AS+
K081022 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared May 29, 2008
19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A
K080951 · LLZ
Totoku Electric Co., Ltd.
Radiology · 56d
Cleared May 29, 2008
15-INCH (38 CM) COLOR LCD MONITOR CDL1576A
K080952 · LLZ
Totoku Electric Co., Ltd.
Radiology · 56d
Cleared May 28, 2008
VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR...
K080934 · JAQ
Nucletron Corporation
Radiology · 56d
Cleared May 28, 2008
WBR XPRESS3.CARDIAC
K081201 · KPS
Ultraspect , Ltd.
Radiology · 30d
Cleared May 28, 2008
ILUMA VISION
K081347 · LLZ
Imtec Corp.
Radiology · 14d
Cleared May 27, 2008
DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM
K081320 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 15d
Cleared May 23, 2008
MROPEN
K073362 · LNH
Paramed S.R.L.
Radiology · 175d
Cleared May 23, 2008
ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202
K081154 · IYO
B-K Medical Aps
Radiology · 30d
Cleared May 20, 2008
OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY)
K081281 · MUJ
Nucletron Corporation
Radiology · 14d
Cleared May 16, 2008
BI-RADS COMPANION
K072258 · LLZ
Almen Laboratories, Inc.
Radiology · 276d
Cleared May 16, 2008
FMRI HARDWARE SYSTEM
K080515 · LNH
Nordicneurolab
Radiology · 81d
Cleared May 16, 2008
SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM
K081110 · IYO
Shantou Institute of Ultrasonic...
Radiology · 28d
Cleared May 15, 2008
MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA
K080582 · KPR
Medicatech USA
Radiology · 73d
Cleared May 15, 2008
IB NEURO, VERSION 1.0
K080762 · LNH
Imaging Biometrics, LLC
Radiology · 58d
Cleared May 14, 2008
SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION
K080701 · IZL
Shimadzu Corp.
Radiology · 64d
Cleared May 14, 2008
CALYPSO 4D LOCALIZATION SYSTEM
K080726 · IYE
Calypso Medical Technologies, Inc.
Radiology · 61d
Cleared May 13, 2008
CORRIDOR4DM
K080575 · KPS
Invia
Radiology · 74d
Cleared May 13, 2008
DENTRON SENSOR
K080738 · EAP
Dentron Systems, LLC
Radiology · 57d
Cleared May 09, 2008
AXXENT VAGINAL APPLICATOR
K072616 · JAD
Xoft, Inc.
Radiology · 235d
Cleared May 09, 2008
LEICA FL800
K080612 · IZI
Leica Microsystems (Schweiz) AG
Radiology · 66d
Cleared May 09, 2008
CHRYSALIS
K080655 · KPR
Meta Imaging Solutions, LLC
Radiology · 63d