Image Quality Analyzer (IQA)

System, Image Management, Ophthalmic

VisionQuest BioMedical, Inc.

The following data is part of a premarket notification filed by Visionquest Biomedical, Inc. with the FDA for Image Quality Analyzer (iqa).

Pre-market Notification Details

Device IDK200422
510k NumberK200422
Device Name:Image Quality Analyzer (IQA)
ClassificationSystem, Image Management, Ophthalmic
Applicant VisionQuest BioMedical, Inc. 2501 Yale Blvd SE #301 Albuquerque,  NM  87106
ContactGilberto Zamora
CorrespondentRyan Bouchard
ORA 300 Brickstone Square Andover,  MA  01810
Product CodeNFJ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-20
Decision Date2020-12-24

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