# K221803: PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress.

- Pathway: 510(k) (Special)
- Applicant: Sedecal., Sa.
- Decided: Jul 18, 2022 after 26 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: 11 generations back to K896095 (1990). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212291: Phoenix, Sedecal., Sa. (2021) Summary page 4.

## Recalls of this device
- Feb 6, 2023 · Class II · Z-1203-2023: 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/K221803
Methodology: https://510kreport.com/methodology