Cleared Traditional

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

K251061 · Siemens Medical Solutions USA, Inc. · Radiology
Jul 2025
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K251061 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 July 28, 2025, 115 days after receiving the submission on April 4, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K251061 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2025
Decision Date July 28, 2025
Days to Decision 115 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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