Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles— 510(k) K202267
Substantially EquivalentIsoray Medical, Inc.
FDA 510(k) clearance K202267 for Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles, Substantially Equivalent on 2020-12-31. Applicant: Isoray Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Isoray Medical, Inc.
- Product code
- Code KXK
- Device class
- Class 2
- Regulation
- 21 CFR 892.5730
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Richland, WA, US
Recent devices under product code KXK
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