Name: Predicase
Price: 199 USD

K-number	K202267
Device name	Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles
Applicant	Isoray Medical, Inc.
Product code	KXK
Device class	Class II
Decision date	Dec 31, 2020
Decision	Substantially Equivalent
Regulation	892.5730

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 →

Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles

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