FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
5737–5760 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 29, 2011
SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT
K113680 · IYO
Soma Access Systems, LLC
Radiology · 14d
Cleared Dec 29, 2011
GE LOGIQ I, LOGIQ E AND VIVID E
K113690 · IYN
Ge Healthcare
Radiology · 14d
Cleared Dec 28, 2011
DELTAVIEW MODEL 2.1
K111776 · LLZ
Riverain Medical Group,Llc
Radiology · 188d
Cleared Dec 27, 2011
PROCEDURE REHEARSAL STUDIO(TM)
K112387 · LLZ
Simbionix , Ltd.
Radiology · 131d
Cleared Dec 23, 2011
KONICA MINOLTA XPRESS DIGITAL MAMMOGRAPHY SYSTEM
K110717 · MUE
Konica Minolta Medical & Graphic, Inc.
Radiology · 283d
Cleared Dec 23, 2011
1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL
K111673 · MOS
Invivo Corporation
Radiology · 191d
Cleared Dec 23, 2011
21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)
K113443 · LLZ
Totoku Electric Co., Ltd.
Radiology · 32d
Cleared Dec 22, 2011
SENOGRAPHE DS, SENOGRAPHE ESSENTIAL
K110798 · MUE
General Electric Company
Radiology · 275d
Cleared Dec 22, 2011
CR MAMMOGRAPHY SYSTEM WITH DX-M DIGITIZER
K111324 · MUE
Agfa Healthcare N.V.
Radiology · 225d
Cleared Dec 22, 2011
THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA...
K112109 · LLZ
Ortho Kinematics, Inc.
Radiology · 153d
Cleared Dec 22, 2011
TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER
K112776 · MUJ
Tomotherapy Incorporated
Radiology · 87d
Cleared Dec 22, 2011
SYNAPSE MPR FUSION
K113244 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 50d
Cleared Dec 20, 2011
METRON-CP/MD
K103554 · LLZ
Eponatech, LLC
Radiology · 382d
Cleared Dec 20, 2011
21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)
K113136 · LLZ
Totoku Electric Co., Ltd.
Radiology · 57d
Cleared Dec 17, 2011
HD-IVUS ULTRASOUND IMAGING SYSTEM
K112997 · IYN
Silicon Vally Medical Instruments, Inc.
Radiology · 71d
Cleared Dec 17, 2011
8MP COLOR LCD MONITOR,RADIFORCE RX840
K113226 · LLZ
Eizo Nanao Corporation
Radiology · 46d
Cleared Dec 17, 2011
BIOGRAPH MCT FAMILY
K113448 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 26d
Cleared Dec 16, 2011
PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202
K100919 · IYN
B-K Medical Aps
Radiology · 623d
Cleared Dec 16, 2011
INTEGRITY(TM)
K112613 · IYE
Elekta Limited
Radiology · 100d
Cleared Dec 16, 2011
CLEARSTART SVM SYSTEM
K113541 · LLZ
Intio, Inc.
Radiology · 15d
Cleared Dec 16, 2011
ONDEMAND3D
K113543 · LLZ
Cybermed, Inc.
Radiology · 15d
Cleared Dec 16, 2011
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM
K113647 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 4d
Cleared Dec 15, 2011
INTRAORAL BELSENSOR GOLD
K102456 · MUH
Takara Belmont USA, Inc.
Radiology · 475d
Cleared Dec 13, 2011
VIEW 1 IMAGING
K112480 · LLZ
KARL STORZ Endoscopy-America, Inc.
Radiology · 106d