FDA 510(k)

Vita Flex CR System with LLI

K-Number: K192894 · 2020-02-18

Decision Date2020-02-18

Product CodeMQB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Vita Flex CR System with LLI is a medical device manufactured by Carestream Health, Inc.. It received FDA 510(k) clearance on 2020-02-18 under approval number K192894. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vita Flex CR System with LLI?

Vita Flex CR System with LLI is a medical device that received FDA 510(k) clearance on 2020-02-18. It is manufactured by Carestream Health, Inc.. The 510(k) number is K192894.

When was Vita Flex CR System with LLI approved by the FDA?

Vita Flex CR System with LLI received FDA 510(k) clearance on 2020-02-18, under approval number K192894.

What company makes Vita Flex CR System with LLI?

Vita Flex CR System with LLI is manufactured by Carestream Health, Inc..

What is the FDA product code for Vita Flex CR System with LLI?

The FDA product code for Vita Flex CR System with LLI is MQB.

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Official Source

View on FDA Database →

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