# K073271: Orthogon

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare Corporation
- Decided: Dec 5, 2007 after 14 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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 K896095 (1990). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071972: Orthopedic Software for Impax Workstations, Agfa Healthcare Corp. (2007) Summary page 1.
- K042816: Traumacad 1.2, Orthocrat, Ltd. (2004) Summary page 1.

## Indications for use
OrthoGon is a plug-in software application for PACS workstations. The package is indicated to assist clinicians in their analysis of anatomy and pathology by providing interactive 2D measurement schemes and comparisons against prior measurements and against normative references to aid in the diagnosis of disorders and deformities. OrthoGon is intended for use in the fields of musculoskeletal radiology, orthopedics, traumatology and pediatrics using 2D X-ray images based on DICOM standards. The application is intended for use by radiologists, radiographers, technologists, referring physicians and orthopedic surgeons and can be used in operating theaters, mobile and military environments.

Source page: https://510kreport.com/device/K073271
Methodology: https://510kreport.com/methodology