GammaTile— 510(k) K180515
Substantially EquivalentIsoray Medical, Inc.
FDA 510(k) clearance K180515 for GammaTile, Substantially Equivalent on 2018-07-06. 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
view allMore clearances from Isoray Medical, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.