FILM DIGITIZER MODEL 2905

Digitizer, Image, Radiological

ARRAY CORP.

The following data is part of a premarket notification filed by Array Corp. with the FDA for Film Digitizer Model 2905.

Pre-market Notification Details

Device IDK982785
510k NumberK982785
Device Name:FILM DIGITIZER MODEL 2905
ClassificationDigitizer, Image, Radiological
Applicant ARRAY CORP. 3-42-10 YOYOGI, SHIBUYA-KU Tokyo,  JP 151-0053
ContactTakashi Inami
CorrespondentTakashi Inami
ARRAY CORP. 3-42-10 YOYOGI, SHIBUYA-KU Tokyo,  JP 151-0053
Product CodeLMA  
CFR Regulation Number892.2030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-07
Decision Date1998-10-15
Summary:summary

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