IMAGERT

Accelerator, Linear, Medical

IMPAC MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Impac Medical Systems, Inc. with the FDA for Imagert.

Pre-market Notification Details

Device IDK942346
510k NumberK942346
Device Name:IMAGERT
ClassificationAccelerator, Linear, Medical
Applicant IMPAC MEDICAL SYSTEMS, INC. 209 HAMILTON AVE. Palo Alto,  CA  94301
ContactJoseph K Jachnowski
CorrespondentJoseph K Jachnowski
IMPAC MEDICAL SYSTEMS, INC. 209 HAMILTON AVE. Palo Alto,  CA  94301
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-16
Decision Date1995-05-15

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