Last synced on 4 July 2025 at 11:05 pm

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202267
510(k) Type
Traditional
Applicant
Isoray Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/31/2020
Days to Decision
142 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K202267
510(k) Type
Traditional
Applicant
Isoray Medical, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/31/2020
Days to Decision
142 days
Submission Type
Summary