MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH

Assembly, Tube Housing, X-ray, Diagnostic

ABSOLUTE X-RAY CORP.

The following data is part of a premarket notification filed by Absolute X-ray Corp. with the FDA for Mammographic Model Cxr 51 Mo-6'/0.6 Sh.

Pre-market Notification Details

Device IDK864042
510k NumberK864042
Device Name:MAMMOGRAPHIC MODEL CXR 51 MO-6'/0.6 SH
ClassificationAssembly, Tube Housing, X-ray, Diagnostic
Applicant ABSOLUTE X-RAY CORP. 23-06 31 AVE. Long Island City,  NY  11106
ContactGeorge S Pavel
CorrespondentGeorge S Pavel
ABSOLUTE X-RAY CORP. 23-06 31 AVE. Long Island City,  NY  11106
Product CodeITY  
CFR Regulation Number892.1760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-16
Decision Date1986-10-27

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