ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT

System, X-ray, Fluoroscopic, Image-intensified

AUSONICS PTY LTD.

The following data is part of a premarket notification filed by Ausonics Pty Ltd. with the FDA for Alpha Mc-9s Mobil C-arm Image Intensifier Unit.

Pre-market Notification Details

Device IDK883372
510k NumberK883372
Device Name:ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
ClassificationSystem, X-ray, Fluoroscopic, Image-intensified
Applicant AUSONICS PTY LTD. 40 CRANE HILL RD. Suffield,  CT  06078
ContactWilliam C Nealon
CorrespondentWilliam C Nealon
AUSONICS PTY LTD. 40 CRANE HILL RD. Suffield,  CT  06078
Product CodeJAA  
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-10
Decision Date1988-11-25

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