# K212291: Phoenix

- Pathway: 510(k) (Traditional)
- Applicant: Sedecal., Sa.
- Decided: Sep 14, 2021 after 54 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K896095 (1990). 21 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192011: PhoeniX, Sedecal., Sa. (2019) Summary page 4.

## Most influential descendants
- K222951: SM-V (2022), 1 descendant of its own
- K232185: SM-IV (2023), 0 descendants of its own
- K231577: MOBILETT Impact (2023), 0 descendants of its own
- K221803: PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. (2022), 0 descendants of its own

## Recalls of this device
- Feb 6, 2023 · Class II · Z-1202-2023: Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.

## Indications for use
This is a digital mobile diagnostic x-ray system intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

Source page: https://510kreport.com/device/K212291
Methodology: https://510kreport.com/methodology