# K222781: Augmento

- Pathway: 510(k) (Traditional)
- Applicant: Deeptek Medical Imaging Private Limited
- Decided: Apr 11, 2023 after 208 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: 7 generations back to K942120 (1994). 10 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K211480: NubeX, Techheim Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- 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
Augmento is a web-based PACS and radiology workflow management solution. It receives digital images and data from various DICOM compliant sources (i.e. CT scanners, MR scanners, ultrasound systems, RF Units, PET Units, computed & digital radiographic devices, secondary capture devices, imaging gateways, and other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and/or across computer networks at distributed locations. Only preprocessed DICOM "for presentation" images can be interpreted for primary image diagnosis in mammography. Lossy compressed images and digitized film screens of mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specifications identified by the FDA. This system is meant to be used by trained and qualified medical professionals, e.g physicians, radiologists, nurses, and medical technicians.

Source page: https://510kreport.com/device/K222781
Methodology: https://510kreport.com/methodology