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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 the device name listed in this FDA 510(k) record. The listed applicant is Isoray Medical, Inc.. It received FDA 510(k) clearance on 2020-12-31 under 510(k) 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. The listed applicant is Isoray Medical, Inc.. The 510(k) number is K202267.

When did Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles receive FDA 510(k) clearance?

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 510(k) number K202267.

Who is the listed applicant for Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles?

The FDA 510(k) record lists Isoray Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Isoray Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180515GammaTile

Related Devices (Code: KXK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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