# K020436: Portable X-Ray Units; Models SP-HF-2.8 & SP-HF-4.0

- Pathway: 510(k) (Abbreviated)
- Applicant: Sedecal., Sa.
- Decided: Feb 22, 2002 after 14 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
No predicates in its family tree.
25 later devices descend from it; 2 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)
- None. The FDA summary names its predicate without a number.
- (no number) MinXray HF100H: named in the summary without a submission number

## Most influential descendants
- K042361: Digital Portable X-Ray Units, Model SP-HF-4.0 D (2004), 22 descendants of its own
- K082627: Minxray, Model CMDR-1S and CMDR-1S-Mil (2008), 15 descendants of its own
- K100449: Minxray Model CMDR-2S (2010), 14 descendants of its own
- K141885: CMDR-2ST & CMDR-2SLWT Digital Portable X-Ray (2014), 13 descendants of its own
- K171353: CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris (2017), 12 descendants of its own

## Recalls of this device
- Oct 27, 2003 · Not classified · Z-0001-04: A minimum source-skin-distance of less than 30 cm and not identifying the tube manufacturer on the tube housing label resulted in the SP-HF-4.0 Portable Systems not complying with the U.S. Federal per

## Indications for use
Models SP-HF-2.8 and SP-HF-4.0 Portable X-ray Units are intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays.

Source page: https://510kreport.com/device/K020436
Methodology: https://510kreport.com/methodology