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FDA 510(k)

ClearRead CT CAC

K-Number: K242188 · 2024-12-03

ApplicantRiverain Technologies, Inc.
Decision Date2024-12-03
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ClearRead CT CAC 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 2024-12-03 under 510(k) number K242188. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearRead CT CAC?

ClearRead CT CAC is a medical device that received FDA 510(k) clearance on 2024-12-03. The listed applicant is Riverain Technologies, Inc.. The 510(k) number is K242188.

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

ClearRead CT CAC received FDA 510(k) clearance on 2024-12-03, under 510(k) number K242188.

Who is the listed applicant for ClearRead CT CAC?

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 CAC?

The FDA product code for ClearRead CT CAC is JAK.

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.

K221612ClearRead CTK213566ClearRead Xray PneumothoraxK161201ClearRead 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.

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