PYLARIFY AI 602
GUDID 07350002336021
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 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 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 | 07350002336021 |
| NIH Device Record Key | 9a88c73f-bb30-4815-b2bb-3807e8a88144 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PYLARIFY AI |
| Version Model Number | 02 |
| Catalog Number | 602 |
| 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 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com | |
| Phone | +46462865420 |
| support@exini.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07350002336021 [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 | 2022-09-19 |
| Device Publish Date | 2022-09-09 |
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 |
Trademark Results [PYLARIFY AI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PYLARIFY AI 97388595 not registered Live/Pending |
Progenics Pharmaceuticals, Inc. 2022-04-29 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.