Vitrea Software Package VSTP-002A
by Canon Medical Systems Corporation
510(k) K223336
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK223336 | Date9 Jan 2023 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Vitrea Software Package VSTP-002A is a portfolio of medical imaging software applications designed for advanced visualization within the Vitrea workstation platform. It functions as a multi-modality tool, enabling the processing, analysis, and display of diagnostic images from various imaging modalities. The software integrates with internal databases to facilitate image importation and management, supporting workflows in radiology and diagnostic imaging environments.
This software is supplied as part of the Vitrea workstation ecosystem and is intended for use in clinical settings where radiologists and imaging specialists review and analyze medical images. It is not a single-use or reusable device but rather a software solution that requires installation on compatible hardware. The product holds FDA 510(k) clearance under the Radiology advisory committee, with a clearance type classified as Traditional. No sterility or physical size specifications apply, as it is a digital application.
Other devices from Canon Medical Systems Corporation
Questions
AI-generated answers, 1 Oct 2026
What is the Vitrea Software Package VSTP-002A used for?
The Vitrea Software Package VSTP-002A is designed for advanced visualization and analysis of diagnostic images across multiple imaging modalities within a clinical radiology setting. It processes, analyzes, and displays images to assist radiologists and imaging specialists in reviewing and interpreting medical scans, improving diagnostic accuracy and workflow efficiency.
How is the Vitrea VSTP-002A supplied and installed?
The Vitrea VSTP-002A is supplied as part of the Vitrea workstation ecosystem and is not a physical device but a software solution. It requires installation on compatible hardware within a clinical environment. The software integrates with internal databases to streamline image importation and management, ensuring seamless operation within existing radiology infrastructure.
Is the Vitrea VSTP-002A single-use or reusable?
The Vitrea VSTP-002A is neither single-use nor reusable in the traditional sense. It is a software application that must be installed on compatible hardware and remains functional for ongoing use within the clinical setting. The software’s utility depends on its continuous integration with the Vitrea workstation platform and its ability to process and analyze diagnostic images repeatedly.
Does the Vitrea VSTP-002A require sterility or have physical size specifications?
No, the Vitrea VSTP-002A does not have sterility requirements or physical size specifications. As a digital software solution, it operates entirely within the Vitrea workstation environment and does not involve physical components that would necessitate such considerations. Its functionality is entirely dependent on the hardware and software compatibility of the installed system.
What regulatory clearance does the Vitrea VSTP-002A hold?
The Vitrea Software Package VSTP-002A holds FDA 510(k) clearance under the Radiology advisory committee, classified as a Traditional clearance type. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness in its intended clinical use.