K-number	K200213
Device name	Biograph mMR with syngo MR E11P-AP01 system software
Applicant	Siemens Medical Solutions USA, Inc.
Product code	OUO
Device class	Class II
Decision date	May 11, 2020
Decision	Substantially Equivalent
Regulation	892.1200

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

Biograph mMR with syngo MR E11P-AP01 system software

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