# K211480: NubeX

- Pathway: 510(k) (Traditional)
- Applicant: Techheim Co., Ltd.
- Decided: Jul 8, 2021 after 57 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: 6 generations back to K942120 (1994). 9 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163290: INFINITT ULite, Infinitt Co., Ltd. (2017) Summary page 5.

## Most influential descendants
- K222781: Augmento (2023), 4 descendants of its own
- K232891: Carpl (Carpl) (2024), 2 descendants of its own
- K260936: RadioViewAI (2026), 0 descendants of its own
- K253008: maiLink (2026), 0 descendants of its own
- K242838: QuickRad (2025), 0 descendants of its own

## Indications for use
NubeX, PACS is a software device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Only preprocessed 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 a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g physicians, radiologists, nurses, and medical technicians.

Source page: https://510kreport.com/device/K211480
Methodology: https://510kreport.com/methodology