LORAD D-550

System, X-ray, Mammographic

LORAD CORP.

The following data is part of a premarket notification filed by Lorad Corp. with the FDA for Lorad D-550.

Pre-market Notification Details

Device IDK934870
510k NumberK934870
Device Name:LORAD D-550
ClassificationSystem, X-ray, Mammographic
Applicant LORAD CORP. 36 APPLE RIDGE RD. Danbury,  CT  06810
ContactPhilip Juhas
CorrespondentPhilip Juhas
LORAD CORP. 36 APPLE RIDGE RD. Danbury,  CT  06810
Product CodeIZH  
CFR Regulation Number892.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-12
Decision Date1994-01-31

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