# K193262: DR 600 with Tomosynthesis

- Pathway: 510(k) (Traditional)
- Applicant: Agfa N.V.
- Decided: Mar 9, 2020 after 104 days
- Product code: IZF (System, X-Ray, Tomographic)
- Device class: 2
- Regulation: 21 CFR 892.1740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K803130 (1981). 38 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183275: DR 800 with Tomosynthesis, Agfa N.V. (2019) Summary page 4.
- K152639: DR 600, Agfa Healthcare N.V. (2015) Summary page 4.

## Most influential descendants
- K222934: Nanox.ARC (2023), 3 descendants of its own
- K242395: Nanox.ARC (2024), 2 descendants of its own
- K250850: Nanox.ARC X (2025), 1 descendant of its own
- K252649: TAP2D (2026), 0 descendants of its own

## Indications for use
The DR 600 system is a General Radiography X-ray imaging system used in hospitals, clinics and medical practices by radiographers, radiologists and physicists 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. In addition, the system provides the Agfa tomosynthesis option, which is intended to acquire tomographic slices of human anatomy and to be used with Agfa DR X-ray systems. Digital tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. Applications can be performed with the patient in the sitting, standing or lying position. This system is not intended for mammography applications.

Source page: https://510kreport.com/device/K193262
Methodology: https://510kreport.com/methodology