Identity
- Trade Name
- Visix FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Visix 8.1 software Build 81 FDA UDI
- Model / Reference
- 8.1 Build 81 FDA UDI
- Description
- Visix 8.1 software Build 81 FDA UDI
Identifiers
- Catalog Number
- Visix 8.1 Build 81 FDA UDI
- Primary DI / UDI-DI
- 00851800007054 FDA UDI
- 510(k) Number
- K082623 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Commercial Distribution
- 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
No
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
Category: Radiological PACS softwareBasic diagnostic x-ray system application softwareGeneral-purpose dental x-ray system application softwareCamera application software
Visix by Televere Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K082623 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Televere Systems
Sources (1)
- FDA UDI 9000571d-9a16-47ac-b674-7646815b9b74 36 fields · synced May 30, 2026