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
8593–8616 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 21, 2003
CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION
K031638 · LLZ
Electromed Imaging, Inc.
Radiology · 55d
Cleared Jul 21, 2003
CORIX 70 PLUS-USV
K031802 · EHD
Coramex, S.A.
Radiology · 40d
Cleared Jul 21, 2003
SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM
K032114 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 12d
Cleared Jul 21, 2003
SITE-RITE IV ULTRASOUND SYSTEM
K032135 · IYO
Dymax Corp
Radiology · 10d
Cleared Jul 18, 2003
PRIMA III TOTALSENSE TORSO COIL
K031365 · MOS
Usa Instruments, Inc.
Radiology · 79d
Cleared Jul 18, 2003
ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX
K031504 · KNG
Koven Technology, Inc.
Radiology · 65d
Cleared Jul 18, 2003
BRAIN COIL, MODEL 9900GE-64
K031536 · MOS
Clinical MR Solutions, LLC
Radiology · 63d
Cleared Jul 18, 2003
STEREOTACTIC BODY FRAME, MODEL COD. 70-1A
K031631 · IYE
3D Line USA, Inc.
Radiology · 52d
Cleared Jul 18, 2003
MODIFICATION TO WBR, MODEL HR
K031874 · KPS
U.C.G. Technologies , Ltd.
Radiology · 31d
Cleared Jul 18, 2003
SCANTEC PAD
K031894 · MUI
Sonotech, Inc.
Radiology · 29d
Cleared Jul 18, 2003
PHILIPS VIEWFORUM 2003
K032096 · LLZ
Philips Medical Systems
Radiology · 10d
Cleared Jul 18, 2003
ACUSON CV70 CARDIOVASCULAR SYSTEM
K032111 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 9d
Cleared Jul 17, 2003
PHILLIPS OMNIDIAGNOST ELEVA
K032046 · OWB
Philips Medical Systems, Inc.
Radiology · 15d
Cleared Jul 15, 2003
MAYO CLINIC BC-10 1.5T
K031119 · MOS
Mayo Medical Ventures
Radiology · 98d
Cleared Jul 15, 2003
AMERITEK SURE-POINT HDR NEEDLE TEMPLATE
K031273 · JAQ
Amertek Medical, Inc.
Radiology · 84d
Cleared Jul 11, 2003
PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL
K031366 · MOS
Usa Instruments, Inc.
Radiology · 72d
Cleared Jul 11, 2003
GEMINI 16
K032036 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 10d
Cleared Jul 08, 2003
INTRAOS 70
K031118 · EHD
Blue X Imaging Srl
Radiology · 91d
Cleared Jul 08, 2003
5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION
K031929 · LLZ
Wide Corporation
Radiology · 15d
Cleared Jul 02, 2003
READI-STRAND, MODEL PSSTRAND
K023179 · KXK
Worldwide Medical Technologies, LLC
Radiology · 281d
Cleared Jul 02, 2003
PERSONAL DIGITAL WORKSTATION (PDW)
K031372 · LLZ
Maxxvision, LLC
Radiology · 63d
Cleared Jul 02, 2003
GE DELTA SOFTWARE OPTION FOR MRI
K031927 · LNH
GE Medical Systems
Radiology · 9d
Cleared Jun 30, 2003
SONOVIEW PRO BY MEDISON CO., LTD.
K031886 · LLZ
Medison Co., Ltd.
Radiology · 12d
Cleared Jun 24, 2003
UF BRACHYTHERAPY STAND
K023430 · IYO
University of Florida
Radiology · 256d