aBSI 203

GUDID 07350002332030

Radiology DICOM image processing application software

Primary Device ID	07350002332030
NIH Device Record Key	0e7aea2c-62d8-4ce9-bae9-d42a92e71882
Commercial Distribution Status	In Commercial Distribution
Brand Name	aBSI
Version Model Number	03
Catalog Number	203
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

Device Issuing Agency	Device ID
GS1	07350002332030 [Primary]

LLZ	System, Image Processing, Radiological

Steralize Prior To Use	false
Device Is Sterile	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	2019-12-23The 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.
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

Mark Image Registration \| Serial	Company Trademark Application Date
ABSI 98674103 not registered Live/Pending	Progenics Pharmaceuticals, Inc. 2024-07-30
ABSI 74733364 not registered Dead/Abandoned	AB SOFTWARE, INC. 1995-09-22
ABSI 74733361 2085319 Dead/Cancelled	AB SOFTWARE, INC. 1995-09-22
ABSI 74733360 not registered Dead/Abandoned	AB SOFTWARE, INC. 1995-09-22
ABSI 74732744 2045536 Dead/Cancelled	AB SOFTWARE, INC. 1995-09-22