SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1

System, Image Processing, Radiological

SECTRA AB

The following data is part of a premarket notification filed by Sectra Ab with the FDA for Sectra Ids5 Radiology Workstation Version 10.1.

Pre-market Notification Details

Device IDK033088
510k NumberK033088
Device Name:SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1
ClassificationSystem, Image Processing, Radiological
Applicant SECTRA AB 1100 LAKEVIEW BLVD. Denton,  TX  76208
ContactCarl Alletto
CorrespondentCarl Alletto
SECTRA AB 1100 LAKEVIEW BLVD. Denton,  TX  76208
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-29
Decision Date2003-10-29
Summary:summary

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