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

FDA 510(k) K202267 · Isoray Medical, Inc.

Substantially Equivalent

510(k) numberK202267

Submission

Device name
Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles
Applicant
Isoray Medical, Inc.
Richland, WA, US
Received
August 11, 2020
Decision date
December 31, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KXK – Source, Brachytherapy, Radionuclide
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5730
Specialty
Radiology
Implant
Yes

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Questions and answers

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

Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles (K202267) received a 510(k) decision of Substantially Equivalent on December 31, 2020, 142 days after the submission was received.

What is the product code of K202267?

The FDA product code is KXK – Source, Brachytherapy, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.5730.