Cleared Abbreviated

AI-Rad Companion (Pulmonary)

K233753 · Siemens Healthcare GmbH · Radiology
Mar 2024
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K233753 is an FDA 510(k) clearance for the AI-Rad Companion (Pulmonary), a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Siemens Healthcare GmbH (Erlangen, DE). The FDA issued a Cleared decision on March 21, 2024, 120 days after receiving the submission on November 22, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K233753 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 2023
Decision Date March 21, 2024
Days to Decision 120 days
Submission Type Abbreviated
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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