ViewPoint 6
by GE Medical Systems Ultrasound and Primary Care Diagnostics 510(k)
Active
510(k) K162743
Overview
The ViewPoint 6 is a radiology information system software designed for ultrasound image and report management. It facilitates the documentation and storage of ultrasound imaging results, enabling radiologists and clinicians to efficiently capture, review, and archive diagnostic findings. This system integrates with ultrasound equipment to streamline workflows and enhance the accuracy of medical reporting.
ViewPoint 6 is supplied as a software solution for use in radiology departments and clinical practice settings. It is intended for single-use sessions per imaging study, though the software itself is reusable across multiple procedures. The device operates within standard clinical IT environments and does not require special sterility measures. Authorized for use in the United States under FDA 510(k) clearance (K162743), it adheres to regulatory standards for radiology information systems and supports efficient diagnostic workflows.
Regulatory status
Recall ongoing. 1 ongoing FDA recall. See recalls
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162743 | Date22 Nov 2016 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Ongoing Z-3146-2024
The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.
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
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Questions
What is the ViewPoint 6 software designed for?
The ViewPoint 6 is a radiology information system software specifically designed to manage ultrasound imaging results. It helps radiologists and clinicians efficiently document, review, and archive diagnostic findings from ultrasound studies. By integrating with ultrasound equipment, it streamlines workflows and improves the accuracy of medical reporting, ensuring that imaging data is organized and accessible for clinical decision-making.
How is the ViewPoint 6 software supplied and used?
The ViewPoint 6 is supplied as a software solution intended for use in radiology departments and clinical practice settings. It is structured for single-use sessions per imaging study, meaning each ultrasound procedure generates a dedicated session within the software. However, the software itself is reusable across multiple procedures, allowing it to support ongoing diagnostic workflows without requiring replacement after each use.
Does the ViewPoint 6 require special sterility measures?
No, the ViewPoint 6 does not require special sterility measures. As a software solution, it operates within standard clinical IT environments and does not involve physical contact with patients or sterile environments. This makes it suitable for routine use in radiology departments without additional sterilization steps.
Is the ViewPoint 6 software reusable or single-use?
The ViewPoint 6 software is reusable across multiple imaging studies, but each ultrasound session is treated as a single-use session for documentation and reporting purposes. This means the software itself remains functional for ongoing use, while individual study data is captured and archived separately for each procedure.
What regulatory clearance does the ViewPoint 6 hold?
The ViewPoint 6 holds FDA 510(k) clearance under the reference number K162743. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device and meets the regulatory standards for radiology information systems in the United States.