# K052545: Infinitt G3 Pacs

- Pathway: 510(k) (Traditional)
- Applicant: Infinitt Co., Ltd.
- Decided: Nov 8, 2005 after 54 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: 4 generations back to K942120 (1994). 7 ancestors in all.
20 later devices descend from it; 4 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042313: Integradweb MPR/Mip, Dynamic Imaging, Inc. (2004) Summary page 1.

## Most influential descendants
- K163290: INFINITT ULite (2017), 6 descendants of its own
- K082990: Infinitt Xelis (2008), 6 descendants of its own
- K211480: NubeX (2021), 5 descendants of its own
- K222781: Augmento (2023), 4 descendants of its own
- K172803: Infinitt PACS 7.0 (2017), 3 descendants of its own

## Indications for use
Infinitt G3 PACS is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, and displayed within the system or across computer networks at distributed locations. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, medical technicians, and assistants.

Source page: https://510kreport.com/device/K052545
Methodology: https://510kreport.com/methodology