CS 7600

System, X-ray, Extraoral Source, Digital

CARESTREAM HEALTH, INC.

The following data is part of a premarket notification filed by Carestream Health, Inc. with the FDA for Cs 7600.

Pre-market Notification Details

Device IDK111649
510k NumberK111649
Device Name:CS 7600
ClassificationSystem, X-ray, Extraoral Source, Digital
Applicant CARESTREAM HEALTH, INC. 1765 THE EXCHANGE Atlanta,  GA  30339
ContactDaniel Hoefer
CorrespondentDaniel Hoefer
CARESTREAM HEALTH, INC. 1765 THE EXCHANGE Atlanta,  GA  30339
Product CodeMUH  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-13
Decision Date2011-09-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
60192151068403 K111649 000
60192151067475 K111649 000
60192151044445 K111649 000
60192151023716 K111649 000
60192151023709 K111649 000
60192151014318 K111649 000
60192151014301 K111649 000
60192151018903 K111649 000

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