Alta Multipurpose Device

Accelerator, Linear, Medical

Qfix

The following data is part of a premarket notification filed by Qfix with the FDA for Alta Multipurpose Device.

Pre-market Notification Details

Device IDK193243
510k NumberK193243
Device Name:Alta Multipurpose Device
ClassificationAccelerator, Linear, Medical
Applicant Qfix 440 Church Road Avondale,  PA  19311
ContactAlexandra Low Smythe
CorrespondentAlexandra Low Smythe
Qfix 440 Church Road Avondale,  PA  19311
Product CodeIYE  
Subsequent Product CodeFRZ
Subsequent Product CodeJAI
Subsequent Product CodeJAK
Subsequent Product CodeKPS
Subsequent Product CodeLHN
Subsequent Product CodeLNH
Subsequent Product CodeOUO
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyRadiology
510k Review PanelRadiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-25
Decision Date2020-02-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10841962110980 K193243 000
10841962110973 K193243 000
10841962110966 K193243 000

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