DST-XL

System, Tomography, Computed, Emission

SOPHA MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Sopha Medical Systems, Inc. with the FDA for Dst-xl.

Pre-market Notification Details

Device IDK942837
510k NumberK942837
Device Name:DST-XL
ClassificationSystem, Tomography, Computed, Emission
Applicant SOPHA MEDICAL SYSTEMS, INC. 7155 COLUMBIA GATEWAY DR. Columbia,  MD  21046 -2101
ContactColin J Mcnaught
CorrespondentColin J Mcnaught
SOPHA MEDICAL SYSTEMS, INC. 7155 COLUMBIA GATEWAY DR. Columbia,  MD  21046 -2101
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-15
Decision Date1995-01-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.