# K031013: Infintt CO., LTD. Starpacs System

- Pathway: 510(k) (Special)
- Applicant: Infinitt Company
- Decided: Apr 17, 2003 after 17 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.
79 later devices descend from it; 4 cite it directly.
0 of 81 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
- K033955: RTIST (2004), 75 descendants of its own
- K101228: Mirada XD (2010), 70 descendants of its own
- K102687: Mirada RT (2010), 37 descendants of its own
- K130393: Mirada RTX (2013), 36 descendants of its own
- K181572: Workflow Box (2018), 25 descendants of its own

## Indications for use
STARPACS TM is a device that receives digital images and data from various sources (i.e. 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.

Source page: https://510kreport.com/device/K031013
Methodology: https://510kreport.com/methodology