Cleared Traditional

MOBILETT Impact

K231577 · Siemens Medical Solutions · Radiology
Jul 2023
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K231577 is an FDA 510(k) clearance for the MOBILETT Impact, a System, X-ray, Mobile (Class II — Special Controls, product code IZL), submitted by Siemens Medical Solutions (Malvern, US). The FDA issued a Cleared decision on July 25, 2023, 55 days after receiving the submission on May 31, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number K231577 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2023
Decision Date July 25, 2023
Days to Decision 55 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZL — System, X-ray, Mobile
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1720

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