# K173299: Dragon X SPSL4HC, Dragon X SPSL8HC

- Pathway: 510(k) (Special)
- Applicant: Sedecal., Sa.
- Decided: Jan 26, 2018 after 101 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K981556 (1998). 9 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121410: Dragon LW, Sedecal., Sa. (2012) Summary page 4.

## Most influential descendants
- K182317: AMADEO M-DR mini, AMADEO M-AX mini (2018), 3 descendants of its own
- K250976: Airbile-100 (2025), 0 descendants of its own
- K212940: Skanmobile, Skanmobile-Dr (2022), 0 descendants of its own
- K183388: JADE Mobile X-Ray (2019), 0 descendants of its own

## Indications for use
These Portable Diagnostic Radiographic Systems are 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/K173299
Methodology: https://510kreport.com/methodology