# K042361: Digital Portable X-Ray Units, Model SP-HF-4.0 D

- Pathway: 510(k) (Special)
- Applicant: Sedecal USA, Inc.
- Decided: Sep 29, 2004 after 29 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: 4 generations back to K981556 (1998). 6 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 29 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). Our OCR of the scanned summary read K020435, FDA’s number for Wound Protector/Retractor (Applied Medical Resources Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Sedecal Portable X-Ray Units”.
- K031447: Canon, Digital Radiography, Model Cxdi-50G, Canon, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K191451: CMDR 2CW (Multiple models) (2019), 11 descendants of its own

## Indications for use
Sedecal Portable X-Ray Units with Detector 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/K042361
Methodology: https://510kreport.com/methodology