# K103522: Sedecal

- Pathway: 510(k) (Special)
- Applicant: Sedecal., Sa.
- Decided: Jan 26, 2011 after 56 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: 1 generation back to K020436 (2002). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020436: Portable X-Ray Units; Models SP-HF-2.8 & SP-HF-4.0, Sedecal., Sa. (2002) Summary page 1.

## Most influential descendants
- K121410: Dragon LW (2012), 5 descendants of its own
- K173299: Dragon X SPSL4HC, Dragon X SPSL8HC (2018), 4 descendants of its own
- K182317: AMADEO M-DR mini, AMADEO M-AX mini (2018), 3 descendants of its own
- K250976: Airbile-100 (2025), 0 descendants of its own
- K222258: Combined High Frequency X-ray Source (2022), 0 descendants of its own

## Indications for use
This Portable Diagnostic Radiographic System is 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/K103522
Methodology: https://510kreport.com/methodology