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
5233–5256 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 25, 2013
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K132509 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 105d
Cleared Nov 22, 2013
MAGNETOM PRISMA, MAGNETOM PRISMA FIT
K132119 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 136d
Cleared Nov 20, 2013
MONACO
K132971 · MUJ
Impac Medical Systems, Inc.
Radiology · 58d
Cleared Nov 20, 2013
I2C
K132847 · LHN
Ion Beam Applications S.A.
Radiology · 70d
Cleared Nov 20, 2013
MULTICAM 3000 ECO
K132347 · KPS
Inter Medical Medizintechnik GmbH
Radiology · 114d
Cleared Nov 20, 2013
MRI MARKER
K131689 · KXK
C4 Imaging, LLC
Radiology · 163d
Cleared Nov 19, 2013
DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM
K132779 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 75d
Cleared Nov 19, 2013
SUMITOMO PROTON THERAPY SYSTEM
K130426 · LHN
Sumitomo Heavy Industries, Ltd.
Radiology · 272d
Cleared Nov 18, 2013
DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS)
K132261 · IZF
Ge Medical Systems, LLC
Radiology · 122d
Cleared Nov 15, 2013
VOLCANO LOMAP,VOLCANO LOMAP OPTION KIT FOR MOBILE SYSTEM,VOLCANO LOMAP OPTION...
K133142 · IYO
Volcano Corporation
Radiology · 29d
Cleared Nov 15, 2013
MAGNETOM AERA
K132951 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 57d
Cleared Nov 15, 2013
DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA...
K132376 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 108d
Cleared Nov 14, 2013
DOSIMETRY CHECK VERSION 4 RELEASE 1
K132605 · IYE
Math Resolutions, LLC
Radiology · 86d
Cleared Nov 14, 2013
DIGITAL COLOR DOPPLER ULTASOUND SYSTEM
K132527 · IYN
Sonoscape Company Limited
Radiology · 94d
Cleared Nov 12, 2013
BIOGRAPH MMR
K133226 · OUO
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Nov 12, 2013
GALAXY AND GALAXY+PLUS DIGITAL RADIOGRAPHY SYSTEMS
K132294 · KPR
Radiology Solutions, LLC
Radiology · 112d
Cleared Nov 12, 2013
INFINIX ANGIO WORKSTATION W/DTS SOFTWARE
K132106 · JAA
Toshiba America Medical Systems, In.C
Radiology · 127d
Cleared Nov 08, 2013
VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10
K132913 · IYN
Ge Healthcare
Radiology · 52d
Cleared Nov 07, 2013
CLARISO PACS
K132799 · LLZ
Clariso, Inc.
Radiology · 62d
Cleared Nov 07, 2013
AQUILION ONE VISION, V6.0
K132222 · JAK
Toshibamedical Systems Corporation
Radiology · 113d
Cleared Nov 07, 2013
G-ARM MULTISCAN SYSTEM
K131423 · OXO
Beijing East Whale Imaging Technology...
Radiology · 175d
Cleared Nov 06, 2013
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K130419 · MUH
Genoray Co., Ltd.
Radiology · 260d
Cleared Nov 05, 2013
DICOMPACS DX-R WITH FLAT PANEL
K131211 · MQB
Oehm Und Rehbein GmbH
Radiology · 190d
Cleared Nov 04, 2013
X-PORTE ULTRASOUND SYSTEM
K133134 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 34d