Name: Predicase
Price: 199 USD

K-number	K251059
Device name	Syngo Carbon Clinicals (VA41)
Applicant	Siemens Healthineers AG
Product code	QIH
Device class	Class II
Decision date	Oct 24, 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

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 →

Syngo Carbon Clinicals (VA41)

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