Cleared Traditional

syngo.MR Applications (VB80)

K253495 · Siemens Healthineers AG · Radiology
Nov 2025
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K253495 is an FDA 510(k) clearance for the syngo.MR Applications (VB80), a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Siemens Healthineers AG (Forchheim, DE). The FDA issued a Cleared decision on November 20, 2025, 23 days after receiving the submission on October 28, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K253495 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2025
Decision Date November 20, 2025
Days to Decision 23 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050