RADIONICS XKNIFE HDRT SYSTEM— 510(k) K083414
Substantially EquivalentIntegra Radionics, Inc.
FDA 510(k) clearance K083414 for RADIONICS XKNIFE HDRT SYSTEM, Substantially Equivalent on 2009-03-02. Applicant: Integra Radionics, Inc.. Device class: 2.
Clearance details
- Applicant
- Integra Radionics, Inc.
- 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
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