# K973219: Amber DU

- Pathway: 510(k) (Traditional)
- Applicant: Oldelft Corp. of America
- Decided: Oct 8, 1997 after 42 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K980296: Oldelft Digidelca (1998), 1 descendant of its own
- K012165: Oldelft Thorascan Model Number 180T (2001), 0 descendants of its own

## Indications for use
Amber DU provides the Radiologist the ability to acquire chest images on film, to digitize these images real time for analysis on the Operator Workstation and retain the ability to analyze the films on a conventional lightbox, and to export the digital images Dicom 3 conformant to the hospital’s network server for storage and eventual retrieval if desired.

Source page: https://510kreport.com/device/K973219
Methodology: https://510kreport.com/methodology