Cleared Traditional

AI-Rad Companion Brain MR

K253057 · Siemens Healthcare GmbH · Radiology

Jan 2026

Decision

122d

Days

Class 2

Risk

About This 510(k) Submission

K253057 is an FDA 510(k) clearance for the AI-Rad Companion Brain MR, a Automated Radiological Image Processing Software (Class II — Special Controls, product code QIH), submitted by Siemens Healthcare GmbH (Erlangen, DE). The FDA issued a Cleared decision on January 22, 2026, 122 days after receiving the submission on September 22, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K253057 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2025
Decision Date	January 22, 2026
Days to Decision	122 days
Submission Type	Traditional
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.