Primary Device ID | 07350002333037 |
NIH Device Record Key | 336a326a-a467-4fe4-b74f-29479e0e78da |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EXINI Bone |
Version Model Number | 03 |
Catalog Number | 303 |
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 |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com | |
Phone | +46462865420 |
support@exini.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07350002333037 [Primary] |
LLZ | System, Image Processing, Radiological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-04-14 |
Device Publish Date | 2023-04-06 |
07350002333037 - EXINI Bone | 2023-04-14EXINI 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 medical image viewers, view and export quantitative analysis values. |
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 | 2019-10-07 EXINI is intended to be used by trained health-care professionals and researchers for acceptance, transfer, storage, image displ |