# K140960: Picture Archiving and Communications System

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Jun 13, 2014 after 59 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: 10 generations back to K954874 (1996). 44 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103385: Securview DX Diagnostic Workstation, Hologic, Inc. (2011) Summary page 1.
- K111694: ASTRA, Candelis, Inc. (2011) Summary page 1.

## Most influential descendants
- K190694: Unifi Workspace v1.0.0 (2019), 2 descendants of its own
- K220767: TeleScan (2022), 1 descendant of its own
- K233634: TeleScan (2023), 0 descendants of its own

## Indications for use
Prima is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving mammography images as well as other medical images and data (e.g. US and MR). images and data can be stored, communicated, and displayed within the system or across computer systems. Prima provides various image processing and measurement tools to facilitate the interpretation of mammography x-ray, breast tomosynthesis, and other multimodality, DICOM medical images and enable diagnosis. Lossy compressed mamnmographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and accepted by the FDA. Prima is typically used by trained professionals, including radiologists, oncologists,surgeons. technologists and clinicians and may provide information to be used for screening and diagnostic procedures.

Source page: https://510kreport.com/device/K140960
Methodology: https://510kreport.com/methodology