S-100 CT SCANNER

System, X-ray, Tomography, Computed

SYNTEX CORP.

The following data is part of a premarket notification filed by Syntex Corp. with the FDA for S-100 Ct Scanner.

Pre-market Notification Details

Device IDK780769
510k NumberK780769
Device Name:S-100 CT SCANNER
ClassificationSystem, X-ray, Tomography, Computed
Applicant SYNTEX CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-05-05
Decision Date1978-06-02

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