FDA 510(k)

ClearRead CT

K-Number: K221612 · 2022-12-05

Decision Date2022-12-05

Product CodeOEB

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ClearRead CT is the device name listed in this FDA 510(k) record. The listed applicant is Riverain Technologies, Inc.. It received FDA 510(k) clearance on 2022-12-05 under 510(k) 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. The listed applicant is Riverain Technologies, Inc.. The 510(k) number is K221612.

When did ClearRead CT receive FDA 510(k) clearance?

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

Who is the listed applicant for ClearRead CT?

The FDA 510(k) record lists Riverain Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearRead CT?

The FDA product code for ClearRead CT is OEB.

Other records listing Riverain Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242188ClearRead CT CAC K213566ClearRead Xray Pneumothorax K161201ClearRead CT

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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.