ViewPoint 6
by Ge Medical Systems Ultrasound And
510(k) K192917
ViewPoint 6 is a Class II device made by Ge Medical Systems Ultrasound And, cleared under FDA 510(k) K192917 on 6 Jan 2020, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK192917 | Date6 Jan 2020 | StatusActive |
Official records
- FDA 510(k) database K192917
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.
Timeline
- Cleared FDA 510(k) K192917
- Recall initiated FDA recalls Z-3146-2024
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- Withdrawn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
Devices cleared under K192917
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ViewPoint 6. ver12 | 6. ver12 | 00840682171953 | — | No longer on the market |
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