WBA - I.R.I.S.

Scanner, Whole Body, Nuclear

SIEMENS GAMMASONICS, INC.

The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Wba - I.r.i.s..

Pre-market Notification Details

Device IDK842895
510k NumberK842895
Device Name:WBA - I.R.I.S.
ClassificationScanner, Whole Body, Nuclear
Applicant SIEMENS GAMMASONICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJAM  
CFR Regulation Number892.1330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-07-23
Decision Date1984-08-27

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