ULTRAPRO WORKSTATION

System, Digital Image Communications, Radiological

RAMSOFT, INC.

The following data is part of a premarket notification filed by Ramsoft, Inc. with the FDA for Ultrapro Workstation.

Pre-market Notification Details

Device IDK942917
510k NumberK942917
Device Name:ULTRAPRO WORKSTATION
ClassificationSystem, Digital Image Communications, Radiological
Applicant RAMSOFT, INC. 37 BANKVIEW CIRCLE Rexdale, Ontario,  CA M9w 6s6
ContactN Ramanathan
CorrespondentN Ramanathan
RAMSOFT, INC. 37 BANKVIEW CIRCLE Rexdale, Ontario,  CA M9w 6s6
Product CodeLMD  
CFR Regulation Number892.2020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-21
Decision Date1994-11-14

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