AccessGUDID - DEVICE: aBSI (07350002332030)

GUDID

Device Identifier (DI) Information

Brand Name: aBSI
Version or Model: 03
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 203
Company Name: Exini Diagnostics AB

Primary DI Number: 07350002332030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 631535262 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57812	Radiology DICOM image processing application software	A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191262	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0e7aea2c-62d8-4ce9-bae9-d42a92e71882
Public Version Date: December 04, 2023
Public Version Number: 3
DI Record Publish Date: October 08, 2019