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FDA-cleared K220590

aPROMISE X

EXINI Diagnostics AB

Authorized purpose: aPROMISE X accepts, stores, displays, manipulates, quantifies, and reports digital medical images from nuclear-medicine imaging using PSMA PET/CT, with tools for marking regions of interest and quantitative oncology review by healthcare professionals or researchers.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Whole-body oncology anatomy represented in PSMA PET/CT studies
Decision
2022-04-29
FDA-cleared K211655

aPROMISE

EXINI Diagnostics AB

Authorized purpose: aPROMISE is a cloud-based platform for healthcare professionals and researchers to accept, transfer, store, display, manipulate, quantify, and report PSMA PET/CT examinations using the PROMISE framework.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Prostate
Decision
2021-07-27
FDA-cleared K191262

aBSI

EXINI Diagnostics AB

Authorized purpose: aBSI analyzes nuclear-medicine whole-body bone scans and SPECT to mark lesions and quantify skeletal disease burden as a fraction of total skeletal weight for trained professionals and researchers; the cloud release does not accept CT or static partial bone scans.

Modality
PET/SPECT/Nuclear Medicine
Anatomy
Bone
Decision
2019-08-05