Stage
FDA 510(k) clearance K223079 · decided 2022-10-28
Clearance details
- K-number
- K223079
- Device name
- Stage
- Applicant
- Spintech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-09-30
- Decision date
- 2022-10-28
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- LNH
- Device class
- 2
- Regulation number
- 892.1000
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bingham Farms, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.