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510(k) K984167

Device
Sage 7
Applicant
GE MEDICAL SYSTEMS
510(k) number
K984167
Product code
LNI
Decision
Substantially Equivalent (SESE)
Decision date
1999-01-12
Date received
1998-11-20
Regulation
892.1000
Classification name
System, Nuclear Magnetic Resonance Spectroscopic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
LARRY A KROGER
Address
3200 N Grandview Blvd. Waukesha WI US 53188 53188

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K011604PROSTATE SPECTROSCOPY AND IMAGING EXAM (PROSE) SOFTWARE OPTION FOR MRIGe Medical Systems, Inc.2001-08-22
K010129EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3Toshiba America Medical Systems, In.C2001-04-05
K003575MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEMGE Medical Systems2001-01-17
K991568MR SPECTROSCOPY PACKAGEPhilips Medical Systems (Cleveland), Inc.1999-07-19
K962627CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEMSiemens Medical Solutions USA, Inc.1997-04-03
K970005GYREX 2T-PRESTIGEElscint, Inc.1997-03-28
K930265HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HTGE Medical Systems1995-04-25