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FDA 510(k)

CVAC Image Processor

K-Number: K260013 · 2026-03-06

ApplicantCalyxo, Inc.
Decision Date2026-03-06
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CVAC Image Processor is a medical device manufactured by Calyxo, Inc.. It received FDA 510(k) clearance on 2026-03-06 under approval number K260013. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CVAC Image Processor?

CVAC Image Processor is a medical device that received FDA 510(k) clearance on 2026-03-06. It is manufactured by Calyxo, Inc.. The 510(k) number is K260013.

When was CVAC Image Processor approved by the FDA?

CVAC Image Processor received FDA 510(k) clearance on 2026-03-06, under approval number K260013.

What company makes CVAC Image Processor?

CVAC Image Processor is manufactured by Calyxo, Inc..

What is the FDA product code for CVAC Image Processor?

The FDA product code for CVAC Image Processor is FGB.

Other Devices by Calyxo, Inc.

K233472CVAC Aspiration System + CVAC Image Processor K260965CVAC Aspiration System

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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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