UPACS VERSION 1.7

Device, Digital Image Storage, Radiological

BASE TEN SYSTEMS, INC.

The following data is part of a premarket notification filed by Base Ten Systems, Inc. with the FDA for Upacs Version 1.7.

Pre-market Notification Details

Device IDK961160
510k NumberK961160
Device Name:UPACS VERSION 1.7
ClassificationDevice, Digital Image Storage, Radiological
Applicant BASE TEN SYSTEMS, INC. ONE ELECTTONICS DR. P.O. BOX 3151 TRENTON,  NJ  08619
ContactRICHARD J FARRELLY
CorrespondentRICHARD J FARRELLY
BASE TEN SYSTEMS, INC. ONE ELECTTONICS DR. P.O. BOX 3151 TRENTON,  NJ  08619
Product CodeLMB  
CFR Regulation Number892.2010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-22
Decision Date1996-06-11

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