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FDA 510(k)

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

K-Number: K202267 · 2020-12-31

ApplicantIsoray Medical, Inc.
Decision Date2020-12-31
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles is a medical device manufactured by Isoray Medical, Inc.. It received FDA 510(k) clearance on 2020-12-31 under approval number K202267. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles?

Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles is a medical device that received FDA 510(k) clearance on 2020-12-31. It is manufactured by Isoray Medical, Inc.. The 510(k) number is K202267.

When was Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles approved by the FDA?

Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles received FDA 510(k) clearance on 2020-12-31, under approval number K202267.

What company makes Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles?

Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles is manufactured by Isoray Medical, Inc..

What is the FDA product code for Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles?

The FDA product code for Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles is KXK.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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