Stage
510(k) K223079
Stage is a medical device (FDA Class II; FDA product code LNH, System, Nuclear Magnetic Resonance Imaging) made by Spintech, Inc., cleared under FDA 510(k) K223079 on 28 Oct 2022, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223079 | Date28 Oct 2022 | StatusActive |
Official records
- FDA 510(k) database K223079
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LNH
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K223079
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| STAGE 2 | 2 | 00866463000441 | — | No longer on the market |
| STAGE 2.3 | REF 200008 / 2.3 | 00866463000465 | — | No longer on the market |
| STAGE 2.4 | REF 200009 / 2.4 | 00866463000496 | — | On the market |
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