# K211655: aPROMISE

- Pathway: 510(k) (Traditional)
- Applicant: Exini Diagnostics AB
- Decided: Jul 27, 2021 after 60 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: 13 generations back to K913770 (1991). 234 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 236 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191262: aBSI, Exini Diagnostics AB (2019) Summary page 4.
- K160334: Advanced Medical Imaging Software Suite (KSWVWR), Keosys Sas (2016) Summary page 5.

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

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

Source page: https://510kreport.com/device/K211655
Methodology: https://510kreport.com/methodology