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FDA 510(k)

ASCEND Image Viewer

K-Number: K192372 · 2020-02-14

ApplicantAscend Hit
Decision Date2020-02-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ASCEND Image Viewer is a medical device manufactured by Ascend Hit. It received FDA 510(k) clearance on 2020-02-14 under approval number K192372. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASCEND Image Viewer?

ASCEND Image Viewer is a medical device that received FDA 510(k) clearance on 2020-02-14. It is manufactured by Ascend Hit. The 510(k) number is K192372.

When was ASCEND Image Viewer approved by the FDA?

ASCEND Image Viewer received FDA 510(k) clearance on 2020-02-14, under approval number K192372.

What company makes ASCEND Image Viewer?

ASCEND Image Viewer is manufactured by Ascend Hit.

What is the FDA product code for ASCEND Image Viewer?

The FDA product code for ASCEND Image Viewer is LLZ.

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Official Source

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