Cleared Special

MI View&GO

K254016 · Siemens Medical Solutions USA, Inc. · Radiology

Feb 2026

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K254016 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. (Hoffman Estates, US). The FDA issued a Cleared decision on February 10, 2026, 57 days after receiving the submission on December 15, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K254016 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2025
Decision Date	February 10, 2026
Days to Decision	57 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.