# K233678: Radiography 7000 M

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Dmc GmbH
- Decided: Feb 14, 2024 after 90 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
Longest line of descent: 9 generations back to K981556 (1998). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191813: MobileDiagnost wDR 2.2, Sedecal., Sa. (2019) Summary page 5.

## Recalls of this device
- Sep 18, 2026 · Not classified · Z-0288-2027: Potential for the device to fail immediately after an exposure, causing the system to remain stationary.

## Indications for use
The Radiography 7000 M is intended for diagnostic procedures on both adult and pediatric patients who are unable to be transferred to the stationary X-ray system. It enables radiographic imaging of various body parts, including the skull, chest, spine, shoulders, pelvis, extremities, abdomen, and other body regions. The system allows for applications in different positions, such as sitting, standing, and lying in either a prone or supine position. However, it should be noted that the system is not suitable for mammography applications.

Source page: https://510kreport.com/device/K233678
Methodology: https://510kreport.com/methodology