Cleared Traditional

Open Rib

K223261 · Canon Medical Informatics, Inc. · Radiology
Jul 2023
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K223261 is an FDA 510(k) clearance for the Open Rib, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Canon Medical Informatics, Inc. (Minnetonka, US). The FDA issued a Cleared decision on July 13, 2023, 262 days after receiving the submission on October 24, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K223261 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2022
Decision Date July 13, 2023
Days to Decision 262 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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