# K161345: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR

- Pathway: 510(k) (Special)
- Applicant: Sedecal., Sa.
- Decided: Jul 6, 2016 after 54 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K896095 (1990). 19 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101517: Sedecal Mobile Digital Diagnostic X-Ray, Sedecal., Sa. (2011) Summary page 4.

## Most influential descendants
- 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
- K181874: MX40 Mobile Digital X-ray System (2018), 1 descendant of its own

## Recalls of this device
- Jun 10, 2025 · Class II · Z-0245-2026: 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
- Jun 10, 2025 · Class II · Z-0251-2026: 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
- Jun 10, 2025 · Class II · Z-0244-2026: 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
- Jun 10, 2025 · Class II · Z-0247-2026: 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
- Jun 10, 2025 · Class II · Z-0250-2026: 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
- Jun 10, 2025 · Class II · Z-0252-2026: 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
- Jun 10, 2025 · Class II · Z-0281-2026: 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
- Jun 10, 2025 · Class II · Z-0246-2026: 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
- Jun 10, 2025 · Class II · Z-0248-2026: 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
- Jun 10, 2025 · Class II · Z-0284-2026: 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
- Jun 10, 2025 · Class II · Z-0249-2026: 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
- Jun 10, 2025 · Class II · Z-0285-2026: 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
- Jan 22, 2024 · Class II · Z-1754-2024: Potential interference with the anti-fall system.

## Indications for use
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/K161345
Methodology: https://510kreport.com/methodology