PINNACLE IMAGE PROCESSING SYSTEM

System, Image Processing, Radiological

MEDASYS, INC.

The following data is part of a premarket notification filed by Medasys, Inc. with the FDA for Pinnacle Image Processing System.

Pre-market Notification Details

Device IDK902648
510k NumberK902648
Device Name:PINNACLE IMAGE PROCESSING SYSTEM
ClassificationSystem, Image Processing, Radiological
Applicant MEDASYS, INC. 4651 PLATT RD. Ann Arbor,  MI  48108
ContactRobert R Laskowski
CorrespondentRobert R Laskowski
MEDASYS, INC. 4651 PLATT RD. Ann Arbor,  MI  48108
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-15
Decision Date1990-08-17

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