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
6049–6072 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 09, 2011
RESOLUTIONMD MOBILE MODEL RMB-MOB-2X
K111346 · LLZ
Calgary Scientific, Inc.
Radiology · 119d
Cleared Sep 09, 2011
MRGFUS PELVIC PA COIL MODEL 1.0
K111060 · MOS
Insightech, Ltd.
Radiology · 144d
Cleared Sep 09, 2011
GE VEO RECONSTRUCTION OPTION
K103489 · JAK
General Electric Co.
Radiology · 287d
Cleared Sep 08, 2011
SV BRAIN ARRAY, SIEMENS 3T
K111802 · MOS
Mri Interventions, Inc.
Radiology · 73d
Cleared Sep 08, 2011
XELIS FUSION
K111613 · LLZ
Infinitt Co., Ltd.
Radiology · 91d
Cleared Sep 02, 2011
DIGITAL RADIOGRAPHY
K112309 · MQB
Canon Inc. -Medical Equipment Group
Radiology · 22d
Cleared Sep 02, 2011
DIGITAL RADIOGRAPHY
K111682 · MQB
Canon Inc. -Medical Equipment Group
Radiology · 79d
Cleared Sep 01, 2011
VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM
K112213 · IYN
Ge Healthcare
Radiology · 30d
Cleared Sep 01, 2011
ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
K110729 · MUE
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 169d
Cleared Aug 30, 2011
WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE
K111548 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 88d
Cleared Aug 29, 2011
ACCUVIX A30 DIAGNOSTIC ULTRASOUND SYSTEM
K112339 · IYN
Samsung Medison Co., Ltd.
Radiology · 14d
Cleared Aug 29, 2011
AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY...
K103308 · LLZ
KARL STORZ Endoscopy-America, Inc.
Radiology · 293d
Cleared Aug 26, 2011
ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K103181 · LLZ
Genoray Co., Ltd.
Radiology · 302d
Cleared Aug 25, 2011
SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T...
K112112 · MOS
Sentinel Medical, Inc.
Radiology · 31d
Cleared Aug 25, 2011
AQUILION LB MOVEMENT BASE KIT
K111633 · JAK
Toshiba America Medical Systems, In.C
Radiology · 73d
Cleared Aug 23, 2011
CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE
K111373 · LLZ
Circle Cardiovascular Imaging, Inc.
Radiology · 99d
Cleared Aug 23, 2011
DDRELEMENT
K110828 · KPR
Swissray Medical AG
Radiology · 152d
Cleared Aug 19, 2011
TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001
K111508 · MWP
Hologic, Inc.
Radiology · 79d
Cleared Aug 18, 2011
SYNGO.CT VASCULAR ANALYSIS
K112020 · JAK
Siemens Medi Cal Solutions, Inc.
Radiology · 35d
Cleared Aug 18, 2011
XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT
K111167 · IXW
Velopex International, Inc.
Radiology · 114d
Cleared Aug 18, 2011
TRUEBEAM
K111106 · IYE
Varian Medical Systems, Inc.
Radiology · 120d
Cleared Aug 18, 2011
CS 9300, CS 9300C
K103659 · OAS
Trophy
Radiology · 246d
Cleared Aug 18, 2011
SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING
K103274 · MOS
Sentinelle Medical, Inc.
Radiology · 286d
Cleared Aug 12, 2011
ISROBOT MONA LISA
K111347 · IYO
Biobot Surgical Pte., Ltd.
Radiology · 91d