# K033013: Mdification to Mediprime

- Pathway: 510(k) (Special)
- Applicant: Algotec Systems, Ltd.
- Decided: Nov 25, 2003 after 60 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 K002894 (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)
- K002894: Mediprime, Algotec Systems, Ltd. (2000)
- K023936: Modification to Mediprime, Algotec Systems, Ltd. (2002) Summary page 1.

## Indications for use
The system, that is comprised of diagnostic reading software, is intended for use by radiologists as an interactive tool for analyzing radiological data and generating and viewing radiology reports based on their analysis.

Source page: https://510kreport.com/device/K033013
Methodology: https://510kreport.com/methodology