RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE— 510(k) K041997
Substantially EquivalentRadionics, A Division of Tyco Healthcare Group LP
FDA 510(k) clearance K041997 for RADIONICS XKNIFE RT 3 WITH NON STEREOTACTIC MODULE, Substantially Equivalent on 2004-08-27. Applicant: Radionics, A Division of Tyco Healthcare Group LP. Device class: 2.
Clearance details
- Applicant
- Radionics, A Division of Tyco Healthcare Group LP
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Burlington, MA, US
Recent devices under product code MUJ
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