# K191262: aBSI

- Pathway: 510(k) (Traditional)
- Applicant: Exini Diagnostics AB
- Decided: Aug 5, 2019 after 87 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: 8 generations back to K950279 (1995). 39 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122205: EXINI, Exini Diagnostics AB (2012) Summary page 4.

## Most influential descendants
- K211655: aPROMISE (2021), 1 descendant of its own
- K220590: aPROMISE X (2022), 0 descendants of its own

## Indications for use
aBSI is intended to be used by trained healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images acquired using nuclear medicine (NM) imaging. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including lesion marking and quantitative analysis.

Source page: https://510kreport.com/device/K191262
Methodology: https://510kreport.com/methodology