# K032760: Apax Pacs System

- Pathway: 510(k) (Traditional)
- Applicant: Tis, Inc.
- Decided: Sep 17, 2003 after 12 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: 1 generation back to K010259 (2001). 1 ancestor in all.
19 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010259: Mediface Pacs, Mediface Co., Ltd. (2001)

## Most influential descendants
- K070464: ONDEMAND3D (2007), 14 descendants of its own
- K113543: ONDEMAND3D (2011), 9 descendants of its own
- K131616: EZ3D-I, E3 (2013), 4 descendants of its own
- K150761: Ez3D-i/E3 (2015), 3 descendants of its own
- K040171: Microderm, Model/Version 3.5 (2004), 3 descendants of its own

## Indications for use
The Device is intended to be used by authorized staff to perform medical image management, communications, storage, archiving and review. Images and data can be stored, transmitted (communicated), processed at the workstation, physician's desktop or other clinical application and distributed across networks or the world wide web. Typical users are trained professionals, including not limited to physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K032760
Methodology: https://510kreport.com/methodology