# K041366: Ipacs Ortho

- Pathway: 510(k) (Traditional)
- Applicant: Realtimeimage, Inc.
- Decided: Jun 8, 2004 after 15 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: 2 generations back to K002936 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031590: Sectra Orthopedic Package, Sectra-Imtec AB (2003) Summary page 1.

## Indications for use
iPACS ORTHO TM is intended for the manipulation, displaying, and distribution of medical images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards. The device assists orthopedic surgeons when doing preoperative planning and post-operative follow-up. Typical users of this system are trained professionals, for example orthopedic surgeons, physicians, and radiologists.

Source page: https://510kreport.com/device/K041366
Methodology: https://510kreport.com/methodology