Cleared Traditional

SOMATOM On.site

K241295 · Siemens Medical Solutions USA, Inc. · Radiology
Sep 2024
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K241295 is an FDA 510(k) clearance for the SOMATOM On.site, 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 September 3, 2024, 118 days after receiving the submission on May 8, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K241295 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2024
Decision Date September 03, 2024
Days to Decision 118 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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