Cleared Traditional

AI-Rad Companion (Pulmonary)

K213713 · Siemens Healthcare GmbH · Radiology
Aug 2022
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K213713 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 (Malvern, US). The FDA issued a Cleared decision on August 11, 2022, 260 days after receiving the submission on November 24, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K213713 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2021
Decision Date August 11, 2022
Days to Decision 260 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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