Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon— 510(k) K173789
Substantially EquivalentElekta Instrument AB
FDA 510(k) clearance K173789 for Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Substantially Equivalent on 2018-03-30. Applicant: Elekta Instrument AB. Device class: 2.
Clearance details
- Applicant
- Elekta Instrument AB
- Product code
- Code IWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.5750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stockholm, SE
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