# K012165: Oldelft Thorascan Model Number 180T

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron Corp.
- Decided: Sep 19, 2001 after 70 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
Longest line of descent: 2 generations back to K892659 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980296: Oldelft Digidelca, Oldelft Corp. of America (1998) Summary page 1.

## Indications for use
ThoraScan provides the radiologists or pneumologists the ability to acquire chest x-ray images by filmless radiography (digital radiography), based on a Csl/CCD slot scan detector produced by Thomson TE. The x-ray transmission profile of the chest is converted into an electronic, digital image in real-time. Chest images become available for preview by the x-ray technician on the operator's workstation only seconds after the x-ray exposure. After acceptance by the tech, digital (DICOM) images can be stored on electronic media, as e.g. CD-ROM, magnetic disk, or be exported to a (DICOM/PACS) network, c.q. clinical review station or to a film printer. Note: PACS, networks, clinical review stations and (laser-) film printers are not considered part of the Digidelca system for which this application is filed, only external interfaces tot this type of equipment are defined.

Source page: https://510kreport.com/device/K012165
Methodology: https://510kreport.com/methodology