Identity
- Trade Name
- EXINI FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- EXINI is intended to be used by trained health-care 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 imaging (NM) and computed tomography (CT). The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for oncology including lesion marking and analysis. FDA UDI
- Model / Reference
- 3 FDA UDI
- Description
- EXINI is intended to be used by trained health-care 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 imaging (NM) and computed tomography (CT). The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for oncology including lesion marking and analysis. FDA UDI
Identifiers
- Catalog Number
- 103 FDA UDI
- Primary DI / UDI-DI
- 07350002331033 FDA UDI
- 510(k) Number
- K122205 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
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Exini 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 2abbe4ff-9006-4413-8d3b-3ff5286ada50 37 fields · synced May 31, 2026