bonescanindex.com
exini.comAPROMISE X
EXINI Diagnostics AB
EXINI DIAGNOSTICS AB
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010146120 | 3010146120 | EXINI DIAGNOSTICS AB | 1 | N | 2026-01-01 | Ideon Science Park Scheelevagen 27 LUND Skane SE SE-223 70 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 07350002331033 | EXINI - 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. | +46462865420 | info@exini.com |
| 07350002332030 | aBSI - 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. | +1999999999 | support@bonescanindex.com |
| 07350002333037 | EXINI Bone - EXINI bone is a stand alone software intended for Windows OS platform. Users of the device can import whole body bone scintigraphy image data, view it using 2D medicalimage viewers, view and export quantitative analysis values. | +46462865420 | support@exini.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 146500 | 1889981831 | K220590 | aPROMISE X | LLZ | 2022-04-29 |
| 146500 | 1197007821 | K191262 | aBSI | LLZ | 2019-08-05 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| LLZ | 2 | 2022-04-29 |
PMN#
GUDID#
PYLARIFY AI - 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.
2022-09-09
EXINI Bone - EXINI bone is a stand alone software intended for Windows OS platform. Users of the device can import whole body bone scintigraphy image data, view it using 2D medicalimage viewers, view and export quantitative analysis values.
2023-04-06
aPROMISE - 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.
2023-03-29
PYLARIFY AI - 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.
2021-11-16
aPROMISE - 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.
2021-08-04
aBSI - 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.
2019-10-08
EXINI - 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.
2016-12-16