MODEIFICATION TO IPLAN RT DOSE
FDA 510(k) clearance K080888 · decided 2008-06-11
Clearance details
- K-number
- K080888
- Device name
- MODEIFICATION TO IPLAN RT DOSE
- Applicant
- Brainlab AG
- Decision
- Substantially Equivalent
- Date received
- 2008-03-31
- Decision date
- 2008-06-11
- Days to decision
- 72 days
- Clearance type
- Special
- Product code
- MUJ
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Feldkirchen, DE
- Third-party review
- No
- Expedited review
- No
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