Fx Sps
510(k) K213922
Fx Sps is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Pixee Medical, cleared under FDA 510(k) K213922 on 22 Jul 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 | NumberK213922 | Date22 Jul 2022 | StatusActive |
Official records
- FDA 510(k) database K213922
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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