Cleared Traditional

NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime

K243523 · Siemens Medical Solutions USA, Inc. · Radiology
Feb 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K243523 is an FDA 510(k) clearance for the NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Siemens Medical Solutions USA, Inc. (Knoxville, US). The FDA issued a Cleared decision on February 12, 2025, 90 days after receiving the submission on November 14, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K243523 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2024
Decision Date February 12, 2025
Days to Decision 90 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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