Cleared Special

MULTIX Impact E

K233532 · Siemens Medical Solutions · Radiology
Nov 2023
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K233532 is an FDA 510(k) clearance for the MULTIX Impact E, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Siemens Medical Solutions (Malvern, US). The FDA issued a Cleared decision on November 29, 2023, 27 days after receiving the submission on November 2, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K233532 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2023
Decision Date November 29, 2023
Days to Decision 27 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPR — System, X-ray, Stationary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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