Identity
- Trade Name
- PYLARIFY AI FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 01 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 601 FDA UDI
- Primary DI / UDI-DI
- 07350002336014 FDA UDI
- 510(k) Number
- K211655 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiology DICOM image processing application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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Convenience Kit
No
FDA UDI
Combination Product
No
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HCT/P
No
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Premarket Exempt
No
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Lot / Batch Number
Yes
FDA UDI
Serial Number
No
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Expiration Date
No
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Manufacturing Date
No
FDA UDI
Pylarify Ai by Exini Diagnostics AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Exini Diagnostics AB
Sources (1)
- FDA UDI 0c9fbd5e-8644-489a-bfd9-6344efb5c081 37 fields · synced May 30, 2026