INTEGRA RADIONICS IMAGEFUSION 3— 510(k) K063230
Substantially EquivalentIntegra Radionics, Inc.
FDA 510(k) clearance K063230 for INTEGRA RADIONICS IMAGEFUSION 3, Substantially Equivalent on 2006-12-21. 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
- Special
- Location
- Burlington, MA, US
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