# K040344: Impax OT3000 Orthopedic Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Corp.
- Decided: May 12, 2004 after 90 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: 4 generations back to K913475 (1991). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014113: Endomap, Siemens Medical Solutions USA, Inc. (2002)
- K022292: Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology Clinical Review Satation,Impax Ortho, Agfa Corp. (2002) Summary page 1.
- K993532: DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (Amongst Other Names), Impax Technology, Inc. (1999) Summary page 1.

## Most influential descendants
- K042867: Philips Orthopaedic Applications (2004), 1 descendant of its own
- K060210: Mediport (2006), 0 descendants of its own

## Indications for use
The Agfa IMPAX OT3000 Orthopedic workstation is designed to help orthopedic surgeons and specialists access images, plan surgical procedures, educate patients and monitor patient progress in a digital environment. As an add-on component to the IMPAX client, the OT3000 orthopedic application provides digital planning to images acquired through the PACS system. These images can be utilized to place digital templates that reflect actual prosthetic implants on patients' images helping the surgeon plan the surgical placement of the implant. These plans can be shown to patients to explain the procedure they will undergo and to help them understand the pathology present. The application consists of the following components: * Hip Prosthetic Planning · Knee Prosthetic Planning · Biometry Planning - takes into account patient motion and metrics · Coxometry - tracking of known measurement values in pediatrics to determine surgical intervention · Osteotomy - determines optimum osteotomy locations * Impax Diagnostic Workstation

Source page: https://510kreport.com/device/K040344
Methodology: https://510kreport.com/methodology