# K191884: DR 100s

- Pathway: 510(k) (Traditional)
- Applicant: Agfa N.V.
- Decided: Aug 9, 2019 after 25 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: 7 generations back to K981556 (1998). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103597: DX-D 100, Agfa Healthcare N.V. (2011) Summary page 4.

## Indications for use
The DR 100s system is a mobile X-ray imaging system used in hospitals, clinics and medical practices by radiographers and radiologists to make, process and view static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients. Applications can be performed with the patient in the sitting, standing or lying position. This device is not intended for mammography applications.

Source page: https://510kreport.com/device/K191884
Methodology: https://510kreport.com/methodology