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
7105–7128 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared May 09, 2008
VERISUITE 1.6, VERISUITE-PARTICLE 1.6
K080742 · IYE
Medcom GmbH
Radiology · 53d
Cleared May 09, 2008
4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM...
K081036 · IYE
Varian Medical Systems, Inc.
Radiology · 28d
Cleared May 09, 2008
GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)
K081105 · JAK
Ge Healthcare
Radiology · 21d
Cleared May 09, 2008
MAMMOSITE CAVITY EVALUATION DEVICE
K081179 · JAQ
Hologic, Inc.
Radiology · 14d
Cleared May 05, 2008
BRACHYTHERAPY SOURCE DEVICE, MODEL 9011
K081066 · IWG
Medi-Physics, Inc., Dba GE Healthcare
Radiology · 20d
Cleared May 02, 2008
OEC 9900 ELITE
K073543 · OWB
Ge Oec Medical Systems
Radiology · 137d
Cleared May 02, 2008
CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY
K081079 · JAQ
Senorx, Inc.
Radiology · 16d
Cleared May 02, 2008
CORONIS 5MP MAMMO SL, MODEL MDMG 6121
K081109 · LLZ
Barcoview, Medical Imaging Systems
Radiology · 14d
Cleared May 02, 2008
NORAS MR-BI320-PA 1.5T
K081118 · MOS
Noras Mri Products GmbH
Radiology · 11d
Cleared May 01, 2008
3-D IMAGING WORKSTATION
K081093 · LLZ
Eigen, LLC
Radiology · 14d
Cleared Apr 30, 2008
CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS...
K080791 · JAQ
Senorx, Inc.
Radiology · 41d
Cleared Apr 29, 2008
TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS
K080871 · JAQ
Nucletron Corporation
Radiology · 29d
Cleared Apr 29, 2008
KODAK 9000C EXTRAORAL IMAGING SYSTEM
K080889 · MUH
Trophy
Radiology · 29d
Cleared Apr 29, 2008
SMARTSPOT PRIMAX
K080890 · LLZ
Cmt Medical Technologies, Ltd.
Radiology · 29d
Cleared Apr 29, 2008
S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA
K080968 · LNH
Esaote, S.P.A.
Radiology · 25d
Cleared Apr 29, 2008
GEMINI CONDOR
K081135 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 8d
Cleared Apr 25, 2008
LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A
K073358 · LLZ
Heeyoung Co., Ltd.
Radiology · 148d