PYLARIFY AI

Basic Information

• Brand Name: PYLARIFY AI
• Primary DI: 07350002336014
• Version / Model: 01
• Catalog Number: 601
• Company Name: Exini Diagnostics AB
• Labeler DUNS: 631535262
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-16
• Public Version: 3
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: 0c9fbd5e-8644-489a-bfd9-6344efb5c081
• Distribution End Date: 2022-08-26

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350002336014	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K211655	000