CADSTREAM VERSION 5

System, Image Processing, Radiological

CONFIRMA, INC.

The following data is part of a premarket notification filed by Confirma, Inc. with the FDA for Cadstream Version 5.

Pre-market Notification Details

Device IDK092954
510k NumberK092954
Device Name:CADSTREAM VERSION 5
ClassificationSystem, Image Processing, Radiological
Applicant CONFIRMA, INC. 11040 MAIN STREET SUITE 100 Bellevue,  WA  98004
ContactBrent Lewis
CorrespondentBrent Lewis
CONFIRMA, INC. 11040 MAIN STREET SUITE 100 Bellevue,  WA  98004
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-25
Decision Date2009-11-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842000100638 K092954 000
00842000100881 K092954 000
00842000101031 K092954 000
00842000100003 K092954 000
00842000101116 K092954 000
00842000101178 K092954 000

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