aBSI 203

GUDID 07350002332030

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.

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

• 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

Customer Support Contacts

• Phone: +1999999999
• Email: support@bonescanindex.com
• Phone: +1999999999
• Email: support@bonescanindex.com
• Phone: +1999999999
• Email: support@bonescanindex.com
• Phone: +1999999999
• Email: support@bonescanindex.com
• Phone: +1999999999
• Email: support@bonescanindex.com
• Phone: +1999999999
• Email: support@bonescanindex.com
• Phone: +1999999999
• Email: support@bonescanindex.com
• Phone: +1999999999
• Email: support@bonescanindex.com
• Phone: +1999999999
• Email: support@bonescanindex.com
• Phone: +1999999999
• Email: support@bonescanindex.com
• Phone: +1999999999
• Email: support@bonescanindex.com
• Phone: +1999999999
• Email: support@bonescanindex.com
• Phone: +1999999999
• Email: support@bonescanindex.com
• Phone: +1999999999
• Email: support@bonescanindex.com
• Phone: +1999999999
• Email: support@bonescanindex.com
• Phone: +1999999999
• Email: support@bonescanindex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350002332030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191262

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-10-08

Devices Manufactured by Exini Diagnostics AB

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• 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