# K101517: Sedecal Mobile Digital Diagnostic X-Ray

- Pathway: 510(k) (Special)
- Applicant: Sedecal., Sa.
- Decided: Aug 5, 2011 after 429 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K896095 (1990). 18 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090322: Easy Moving Plus, SM-XXHF-YY, Sedecal., Sa. (2009) Summary page 1.
- K091364: Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4, Oehm Und Rehbein GmbH (2009) Summary page 1.

## Most influential descendants
- K161345: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR (2016), 14 descendants of its own
- K192011: PhoeniX (2019), 8 descendants of its own
- K212291: Phoenix (2021), 4 descendants of its own
- K222951: SM-V (2022), 1 descendant of its own
- K201340: Aquila 320 D / Aquila 320 S (2020), 1 descendant of its own

## Recalls of this device
- Jun 10, 2025 · Class II · Z-0242-2026: 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
- Nov 2, 2018 · Class II · Z-0460-2019: There is a potential for the RadPRO Mobile 40kW Digital X-Ray System Model SM-40HF-B-D-C to separate from the Tube Head Mount and potentially fall off the system.
- Jul 13, 2015 · Class II · Z-2390-2015: Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can generate an Electomagnetic Pulse which might disturb the electronics of the Digital Motion Control Board
- Sep 22, 2014 · Class II · Z-1064-2015: There is a potential for unintended and erratic motion.

## Indications for use
These Digital 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.

Source page: https://510kreport.com/device/K101517
Methodology: https://510kreport.com/methodology