STEREOTACTIC IRRADIATION SYSTEM
FDA 510(k) clearance K904908 · decided 1991-06-06
Clearance details
- K-number
- K904908
- Device name
- STEREOTACTIC IRRADIATION SYSTEM
- Applicant
- Northwest Medical Physics Center
- Decision
- Substantially Equivalent
- Date received
- 1990-10-31
- Decision date
- 1991-06-06
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- IYE
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Lynnwood, WA, US
- Third-party review
- No
- Expedited review
- No
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