aPROMISE 501

GUDID 07350002335017

aPROMISE is a softwareonly medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging within the clinical application of oncology. The device performs by automatic organ and bone segmentation and lesions, selected by the user, will automatically be calculated into a lesion index (LI) and intensityweighted total lesion volume (ITLV). The user of this product is typically a health-care professional using the software to review patient images and analyze results.

Exini Diagnostics AB

Radiology DICOM image processing application software

• Primary Device ID: 07350002335017
• NIH Device Record Key: 7c482232-a1b4-4055-98e3-594b8132c0d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: aPROMISE
• Version Model Number: 01
• Catalog Number: 501
• 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
• Phone: +46462865420
• Email: support@exini.com
• Phone: +46462865420
• Email: support@exini.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350002335017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211655

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: 2021-08-12
• Device Publish Date: 2021-08-04

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