Name: Predicase
Price: 199 USD

K-number	K203645
Device name	Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40
Applicant	Supersonic Imagine
Product code	IYN
Device class	Class II
Decision date	Jun 29, 2021
Decision	Substantially Equivalent
Regulation	892.1550

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 →

Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40

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