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
6001–6024 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 22, 2011
PD-100 SERIES ULTRASONIC POCKET DOPPLER
K111934 · KNG
Advanced Instrumentations, Inc.
Radiology · 76d
Cleared Sep 21, 2011
FM-1000 PLUS FETAL MONITOR
K112187 · HGM
Advanced Instrumentations, Inc.
Radiology · 54d
Cleared Sep 21, 2011
VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET
K111973 · JAQ
Nucletron
Radiology · 71d
Cleared Sep 21, 2011
VIRTUE
K111833 · LLZ
Diagnosoft, Inc.
Radiology · 85d
Cleared Sep 19, 2011
MOBILETT MIRA
K111912 · IZL
Siemens Medical Solutions USA, Inc.
Radiology · 76d
Cleared Sep 19, 2011
EDLEN IMAGING - GEMINI DUSB
K103290 · MUH
Edlen Imaging, LLC
Radiology · 315d
Cleared Sep 16, 2011
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM
K112596 · IYN
Siemens Medical Solutions USA, Inc.,...
Radiology · 9d
Cleared Sep 16, 2011
S8 DIAGNOSTIC ULTRASOUND SYSTEM
K112451 · IYN
Sonoscape Company Limited
Radiology · 22d
Cleared Sep 15, 2011
4CH FLEX SPEEDER
K112366 · MOS
Toshiba Medical Systems Coporation,...
Radiology · 29d
Cleared Sep 15, 2011
MOLECULAR BREAST IMAGING SOFTWARE
K111731 · LLZ
Gamma Medica-Ideas Incorporated
Radiology · 87d
Cleared Sep 15, 2011
ASTRA
K111694 · LLZ
Candelis, Inc.
Radiology · 91d
Cleared Sep 15, 2011
FEEL-DRCS
K110033 · LLZ
Imfou Co., Ltd.
Radiology · 253d
Cleared Sep 15, 2011
EQUAL DOSE
K103515 · MUJ
Nucletron Corporation
Radiology · 289d
Cleared Sep 15, 2011
R4 ACERT ULTRASOUND REPORTING SYSTEM
K101898 · LLZ
R4, LLC
Radiology · 435d
Cleared Sep 13, 2011
XELIS CARDIAC
K111660 · LLZ
Infinitt Co., Ltd.
Radiology · 91d
Cleared Sep 09, 2011
TOSHIBA 3T EXTRA LARGE KNEE COIL
K112313 · MOS
Quality Electrodynamics
Radiology · 29d
Cleared Sep 09, 2011
.DECIMAL ELECTRON APERTURE
K111759 · IXI
.Decimal, Inc.
Radiology · 79d
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