# K012844: Marosis Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Marotech, Inc.
- Decided: Nov 8, 2001 after 77 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.
75 later devices descend from it; 4 cite it directly.
0 of 77 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) Summary page 1.

## Most influential descendants
- K032176: Rattan Imacs by Rattan Information Corporation (2003), 46 descendants of its own
- K063337: Opal-Rad (2006), 45 descendants of its own
- K102123: Vizion DR (2011), 36 descendants of its own
- K112661: Vizion DR (2011), 34 descendants of its own
- K123644: Vizion + DR (2013), 33 descendants of its own

## Indications for use
The Marosis™ PACS System is a device that receives digital images and data from various sources (including but not limited to CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.

Source page: https://510kreport.com/device/K012844
Methodology: https://510kreport.com/methodology