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FDA 510(k)

ClearRead CT

K-Number: K221612 · 2022-12-05

ApplicantRiverain Technologies, Inc.
Decision Date2022-12-05
Product CodeOEB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ClearRead CT is a medical device manufactured by Riverain Technologies, Inc.. It received FDA 510(k) clearance on 2022-12-05 under approval number K221612. The device is classified under product code OEB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearRead CT?

ClearRead CT is a medical device that received FDA 510(k) clearance on 2022-12-05. It is manufactured by Riverain Technologies, Inc.. The 510(k) number is K221612.

When was ClearRead CT approved by the FDA?

ClearRead CT received FDA 510(k) clearance on 2022-12-05, under approval number K221612.

What company makes ClearRead CT?

ClearRead CT is manufactured by Riverain Technologies, Inc..

What is the FDA product code for ClearRead CT?

The FDA product code for ClearRead CT is OEB.

Other Devices by Riverain Technologies, Inc.

K213566ClearRead Xray Pneumothorax K242188ClearRead CT CAC

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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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