| Primary Device ID | 07350002331033 |
| NIH Device Record Key | 2abbe4ff-9006-4413-8d3b-3ff5286ada50 |
| Commercial Distribution Discontinuation | 2017-11-17 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | EXINI |
| Version Model Number | 3 |
| Catalog Number | 103 |
| Company DUNS | 631535262 |
| Company Name | Exini Diagnostics AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| 07350002333037 - EXINI Bone | 2023-04-14 EXINI bone is a stand alone software intended for Windows OS platform. Users of the device can import whole body bone scintigrap |
| 07350002337028 - aPROMISE | 2023-04-06 PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, |
| 07350002336021 - PYLARIFY AI | 2022-09-19 PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, |
| 07350002336014 - PYLARIFY AI | 2021-11-24 PYLARIFY AI is a software only medical device that provides quantitative assessments of standardized uptake values (SUVs) for pa |
| 07350002335017 - aPROMISE | 2021-08-12 aPROMISE is a softwareonly medical device that provides quantitative assessments of standardized uptake values (SUVs) for patien |
| 07350002332030 - aBSI | 2019-12-23 The aBSI is a software-only medical device that provides a fully quantitative assessment of a patient’s skeletal disease on a |
| 07350002331033 - EXINI | 2019-10-07EXINI 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 is
intended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT). The
software provides general Picture Archiving and Communications System (PACS) tools and a clinical application
for oncology including lesion marking and analysis. |
| 07350002331033 - EXINI | 2019-10-07 EXINI is intended to be used by trained health-care professionals and researchers for acceptance, transfer,
storage, image displ |