I-Q View

Solid State X-ray Imager (flat Panel/digital Imager)

First Source, Inc.

The following data is part of a premarket notification filed by First Source, Inc. with the FDA for I-q View.

Pre-market Notification Details

Device IDK203703
510k NumberK203703
Device Name:I-Q View
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant First Source, Inc. 3495 Winton Place, Bldg E Ste 1 Rochester,  NY  14623
ContactSusan Ryan-kron
CorrespondentSusan Ryan-kron
First Source, Inc. 3495 Winton Place, Bldg E Ste 1 Rochester,  NY  14623
Product CodeMQB  
Subsequent Product CodeIZL
Subsequent Product CodeLLZ
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-18
Decision Date2021-03-24

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