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FDA 510(k)

Image Quality Analyzer (IQA)

K-Number: K200422 · 2020-12-24

ApplicantVisionquest Biomedical, Inc.
Decision Date2020-12-24
Product CodeNFJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Image Quality Analyzer (IQA) is the device name listed in this FDA 510(k) record. The listed applicant is Visionquest Biomedical, Inc.. It received FDA 510(k) clearance on 2020-12-24 under 510(k) number K200422. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Image Quality Analyzer (IQA)?

Image Quality Analyzer (IQA) is a medical device that received FDA 510(k) clearance on 2020-12-24. The listed applicant is Visionquest Biomedical, Inc.. The 510(k) number is K200422.

When did Image Quality Analyzer (IQA) receive FDA 510(k) clearance?

Image Quality Analyzer (IQA) received FDA 510(k) clearance on 2020-12-24, under 510(k) number K200422.

Who is the listed applicant for Image Quality Analyzer (IQA)?

The FDA 510(k) record lists Visionquest Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Image Quality Analyzer (IQA)?

The FDA product code for Image Quality Analyzer (IQA) is NFJ.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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