PROTOS SOFTWARE

Accelerator, Linear, Medical

AKTINA MEDICAL PHYSICS CORP.

The following data is part of a premarket notification filed by Aktina Medical Physics Corp. with the FDA for Protos Software.

Pre-market Notification Details

Device IDK040709
510k NumberK040709
Device Name:PROTOS SOFTWARE
ClassificationAccelerator, Linear, Medical
Applicant AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers,  NY  10920
ContactTony Spaccarotella
CorrespondentTony Spaccarotella
AKTINA MEDICAL PHYSICS CORP. 360 NORTH ROUTE 9W Congers,  NY  10920
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-18
Decision Date2004-04-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B365118600 K040709 000

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