MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM

System, Tomography, Computed, Emission

SIEMENS GAMMASONICS, INC.

The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Multispect(tm) 3 Triple Detector Camera System.

Pre-market Notification Details

Device IDK922372
510k NumberK922372
Device Name:MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM
ClassificationSystem, Tomography, Computed, Emission
Applicant SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates,  IL  60195 -7372
ContactIrena Krutulis
CorrespondentIrena Krutulis
SIEMENS GAMMASONICS, INC. 2501 N. BARRINGTON RD. Hoffman Estates,  IL  60195 -7372
Product CodeKPS  
CFR Regulation Number892.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-20
Decision Date1992-08-17

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