Cleared Special

MI View&GO

K242300 · Siemens Medical Solutions USA, Inc. · Radiology
Aug 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K242300 is an FDA 510(k) clearance for the MI View&GO, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Siemens Medical Solutions USA, Inc. (Hiffman Estates, US). The FDA issued a Cleared decision on August 30, 2024, 28 days after receiving the submission on August 2, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K242300 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2024
Decision Date August 30, 2024
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code QIH — Automated Radiological Image Processing Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.