Exini Diagnostics AB

Address:Ideon Science Park,LUND Skane,SE

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- Catalog Number : 103

Device Description : EXINI is intended to be used by trained health-care professionals and researcher EXINI is intended to be used by trained health-care professionals and researchers for acceptance, transfer,storage, image display, manipulation, quantification and reporting of digital medical images. The system isintended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT). Thesoftware provides general Picture Archiving and Communications System (PACS) tools and a clinical applicationfor oncology including lesion marking and analysis.

Device Class : 2

Duns Number: 631535262

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 203

Device Description : The aBSI is a software-only medical device that provides a fully quantitative as The aBSI is a software-only medical device that provides a fully quantitative assessment of a patient’s skeletal disease on a bone scan, as the fraction of the total skeleton weight. The user of this product is typically a health-care professional using the software to view the patient images and analysis results.

Device Class : 2

Duns Number: 631535262

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 501

Device Description : aPROMISE is a softwareonly medical device that provides quantitative assessments aPROMISE is a softwareonly medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging within the clinical application of oncology. The device performs by automatic organ and bone segmentation and lesions, selected by the user, will automatically be calculated into a lesion index (LI) and intensityweighted total lesion volume (ITLV). The user of this product is typically a health-care professional using the software to review patient images and analyze results.

Device Class : 2

Duns Number: 631535262

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 601

Device Description : PYLARIFY AI is a software only medical device that provides quantitative assessm PYLARIFY AI is a software only medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging, using PSMA PET/CT, within the clinical application of oncology. The device performs by automatic organ and bone segmentation and lesions, selected by the user, will automatically be calculated into a lesion index (LI) and intensity-weighted total lesion volume (ITLV). The user of this product is typically a health-care professional using the software to review patient images and analyze results.

Device Class : 2

Duns Number: 631535262

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 602

Device Description : PYLARIFY AI is intended to be used by healthcare professionals and researchers f PYLARIFY AI 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.

Device Class : 2

Duns Number: 631535262

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1