# K141895: Mobilediagnost WDR

- Pathway: 510(k) (Special)
- Applicant: Sedecal., Sa.
- Decided: Sep 18, 2014 after 66 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K981556 (1998). 15 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111725: Mobilediagnost WDR, Sedecal., Sa. (2011) Summary page 4.

## Most influential descendants
- K191813: MobileDiagnost wDR 2.2 (2019), 1 descendant of its own
- K233678: Radiography 7000 M (2024), 0 descendants of its own
- K173187: MobileDiagnost M50 (2017), 0 descendants of its own

## Recalls of this device
- Jun 10, 2025 · Class II · Z-0243-2026: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the po
- Oct 14, 2021 · Class II · Z-1083-2024: While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of t

## Indications for use
Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not for mammography

Source page: https://510kreport.com/device/K141895
Methodology: https://510kreport.com/methodology