LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART

Accelerator, Linear, Medical

INTEGRA RADIONICS, INC.

The following data is part of a premarket notification filed by Integra Radionics, Inc. with the FDA for Linac Collimator Assembly Housing (lcah) Model Lcahart.

Pre-market Notification Details

Device IDK100096
510k NumberK100096
Device Name:LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART
ClassificationAccelerator, Linear, Medical
Applicant INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington,  MA  01803
ContactHelder A Sousa
CorrespondentHelder A Sousa
INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington,  MA  01803
Product CodeIYE  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-13
Decision Date2010-04-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M433LTP1 K100096 000
M248MRCTF21 K100096 000

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