Name: Predicase
Price: 199 USD

K-number	K253495
Device name	syngo.MR Applications (VB80)
Applicant	Siemens Healthineers AG
Product code	LLZ
Device class	Class II
Decision date	Nov 20, 2025
Decision	Substantially Equivalent
Regulation	892.2050

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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syngo.MR Applications (VB80)

Everything you need for a 510(k) submission. Nothing you don't.