Identity
- Trade Name
- Vitrea Software Toshiba Package FDA UDI
- Generic Name
- Radiology DICOM image processing application software FDA UDI
- Device Name
- This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name Vitrea Software Toshiba Package. Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now Vitrea Software Package. FDA UDI
- Model / Reference
- VSTP-001A FDA UDI
- Description
- This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name Vitrea Software Toshiba Package. Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now Vitrea Software Package. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04987670102493 FDA UDI
- 510(k) Number
- K151091 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
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiology DICOM image processing application software
Vitrea Software Toshiba Package by Canon Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Canon Medical Systems Corporation
Sources (1)
- FDA UDI 5fe1b51f-cb4b-41df-8cd7-d8d3afc2e4ce 35 fields · synced May 30, 2026