Phoenix
510(k) K212291
Phoenix is a medical device (FDA Class II; FDA product code IZL, System, X-Ray, Mobile) made by Sedecal., Sa., cleared under FDA 510(k) K212291 on 14 Sep 2021, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212291 | Date14 Sep 2021 | StatusActive |
Official records
- FDA 510(k) database K212291
Recalls
-
- Ongoing Z-1202-2023
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
Timeline
- Cleared FDA 510(k) K212291
- Recall initiated FDA recalls Z-1202-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IZL
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1720
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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