EXINI Bone 303

GUDID 07350002333037

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 medical image viewers, view and export quantitative analysis values.

Exini Diagnostics AB

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software
Primary Device ID07350002333037
NIH Device Record Key336a326a-a467-4fe4-b74f-29479e0e78da
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXINI Bone
Version Model Number03
Catalog Number303
Company DUNS631535262
Company NameExini Diagnostics AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com
Phone+46462865420
Emailsupport@exini.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107350002333037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-14
Device Publish Date2023-04-06

Devices Manufactured by Exini Diagnostics AB

07350002333037 - EXINI Bone2023-04-14EXINI 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 Bone2023-04-14 EXINI bone is a stand alone software intended for Windows OS platform. Users of the device can import whole body bone scintigrap
07350002337028 - aPROMISE2023-04-06 PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display,
07350002336021 - PYLARIFY AI2022-09-19 PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display,
07350002336014 - PYLARIFY AI2021-11-24 PYLARIFY AI is a software only medical device that provides quantitative assessments of standardized uptake values (SUVs) for pa
07350002335017 - aPROMISE2021-08-12 aPROMISE is a softwareonly medical device that provides quantitative assessments of standardized uptake values (SUVs) for patien
07350002332030 - aBSI2019-12-23 The aBSI is a software-only medical device that provides a fully quantitative assessment of a patient’s skeletal disease on a
07350002331033 - EXINI2019-10-07 EXINI is intended to be used by trained health-care professionals and researchers for acceptance, transfer, storage, image displ
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