aPROMISE 702

GUDID 07350002337028

PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear medicine (NM) imaging, using PSMA PET/CT. The device provides general Picture Archiving and Communications System (PACS) tools as well as a clinical application for oncology including marking of regions of interest and quantitative analysis.

Exini Diagnostics AB

Radiology DICOM image processing application software

• Primary Device ID: 07350002337028
• NIH Device Record Key: 51c3bde9-0c68-4557-85cf-5d576d1a3ade
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: aPROMISE
• Version Model Number: 02
• Catalog Number: 702
• 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: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350002337028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220590

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-06
• Device Publish Date: 2023-03-29

On-Brand Devices [aPROMISE]

• 07350002335017: aPROMISE is a softwareonly medical device that provides quantitative assessments of standardized
• 07350002337028: PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, t