Cleared Traditional

ClearRead CT CAC

K242188 · Riverain Technologies, Inc. · Radiology

Dec 2024

Decision

131d

Days

Class 2

Risk

About This 510(k) Submission

K242188 is an FDA 510(k) clearance for the ClearRead CT CAC, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Riverain Technologies, Inc. (Mianisburg, US). The FDA issued a Cleared decision on December 3, 2024, 131 days after receiving the submission on July 25, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number	K242188 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2024
Decision Date	December 03, 2024
Days to Decision	131 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF