HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST

System, X-ray, Stationary

HOLOGIC, INC.

The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Hologic Cer 20/20, Computed Equal Radio Diag Chest.

Pre-market Notification Details

Device IDK913757
510k NumberK913757
Device Name:HOLOGIC CER 20/20, COMPUTED EQUAL RADIO DIAG CHEST
ClassificationSystem, X-ray, Stationary
Applicant HOLOGIC, INC. 590 LINCOLN ST. Waltham,  MA  02154
ContactAitkenhead
CorrespondentAitkenhead
HOLOGIC, INC. 590 LINCOLN ST. Waltham,  MA  02154
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-08-21
Decision Date1991-10-30

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