PYLARIFY AI 601

GUDID 07350002336014

PYLARIFY AI is a software only medical device that provides quantitative assessments of standardized uptake values (SUVs) for patients that are subject to examination by nuclear medicine (NM) imaging, using PSMA PET/CT, 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 intensity-weighted 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: 07350002336014
• NIH Device Record Key: 0c9fbd5e-8644-489a-bfd9-6344efb5c081
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PYLARIFY AI
• Version Model Number: 01
• Catalog Number: 601
• 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: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com
• Phone: (888) 263-4446
• Email: pylarifyai@syntermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350002336014 [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: 2021-11-24
• Device Publish Date: 2021-11-16

On-Brand Devices [PYLARIFY AI]

• 07350002336014: PYLARIFY AI is a software only medical device that provides quantitative assessments of standard
• 07350002336021: PYLARIFY AI is intended to be used by healthcare professionals and researchers for acceptance, t