# K042383: Rsa-CMS

- Pathway: 510(k) (Traditional)
- Applicant: Medis Medical Imaging Systems BV
- Decided: Oct 20, 2004 after 49 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). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041162: Ortho-CMS, Medis Medical Imaging Systems BV (2004) Summary page 1.

## Most influential descendants
- K133966: Model-Based Rsa Software (2014), 0 descendants of its own

## Indications for use
RSA-CMS has been developed for the objective and reproducible analysis on digital roentgen images (DICOM CR or DX) or digitised images in a PACS environment. Orthopedic specialist and core labs use the RSA-CMS standalone analytical software package in image post-processing for the evaluation of new implant designs, coatings and new cementation techniques in clinical trials. When interpreted by trained physicians these parameters may be useful to derive conclusions from these clinical trials. RSA-CMS is developed in close cooperation with the Division of Image Processing (LKEB) and the Department of Orthopedics of the Leiden University Medical Center. It has been validated and complies with international safety and quality standards.

Source page: https://510kreport.com/device/K042383
Methodology: https://510kreport.com/methodology