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FDA 510(k)

AutoContour Model RADAC V2

K-Number: K220598 · 2022-08-24

Decision Date2022-08-24
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AutoContour Model RADAC V2 is a medical device manufactured by Radformation, Inc.. It received FDA 510(k) clearance on 2022-08-24 under approval number K220598. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AutoContour Model RADAC V2?

AutoContour Model RADAC V2 is a medical device that received FDA 510(k) clearance on 2022-08-24. It is manufactured by Radformation, Inc.. The 510(k) number is K220598.

When was AutoContour Model RADAC V2 approved by the FDA?

AutoContour Model RADAC V2 received FDA 510(k) clearance on 2022-08-24, under approval number K220598.

What company makes AutoContour Model RADAC V2?

AutoContour Model RADAC V2 is manufactured by Radformation, Inc..

What is the FDA product code for AutoContour Model RADAC V2?

The FDA product code for AutoContour Model RADAC V2 is QKB.

Other Devices by Radformation, Inc.

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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.