Vivid T8
by Ge Medical Systems Ultrasound and Primary Care Diagnotics, L
510(k) K160078
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160078 | Date10 Mar 2016 | 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- Withdrawn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
- IYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Vivid T8 is a hybrid cardiovascular ultrasound system, classified as a diagnostic ultrasound device. It is designed for echocardiographic imaging, enabling detailed visualization of the heart and surrounding structures to assess cardiac function, anatomy, and pathology. This system supports a range of imaging modalities, including 2D, Doppler, and contrast-enhanced techniques, to enhance diagnostic accuracy and reduce variability between operators.
The Vivid T8 is supplied as a reusable medical device intended for use in clinical settings such as hospitals, cardiac care units, and diagnostic imaging centers. It is not sterile upon delivery and requires appropriate cleaning and maintenance procedures between uses. The system is MRI-unsafe and must be used in environments where magnetic resonance imaging is not performed. Authorized for commercial distribution in the United States under FDA 510(k) clearance (K160078), it adheres to regulatory standards for diagnostic ultrasound devices.
Other devices from Ge Medical Systems Ultrasound and Primary Care Diagnotics, L
Questions
AI-generated answers, 1 Oct 2026
What is the Vivid T8 designed for in clinical practice?
The Vivid T8 is specifically engineered for echocardiographic imaging, allowing clinicians to visualize the heart and adjacent structures with high detail. It supports multiple imaging techniques—including 2D echocardiography, Doppler, and contrast-enhanced imaging—to evaluate cardiac function, anatomy, and pathology. This versatility helps reduce variability between operators and enhances diagnostic confidence for conditions like structural heart disease, valvular disorders, or congenital anomalies.
Is the Vivid T8 intended for single-use or reusable applications?
The Vivid T8 is supplied as a reusable medical device, meaning it is not intended for single-use. After each procedure, it must undergo thorough cleaning and maintenance to ensure proper functionality and infection control. Reusability is typical for high-end diagnostic ultrasound systems used in hospitals and cardiac care units, where durability and repeated use are prioritized.
Does the Vivid T8 come sterile, and what are the cleaning requirements?
The Vivid T8 is not sterile upon delivery and requires appropriate cleaning and maintenance procedures between uses. Since it is a reusable device, adherence to manufacturer guidelines for disinfection and sterilization (if applicable) is critical to prevent cross-contamination. The system’s transducers and probes may have specific cleaning protocols, often involving ultrasound-safe disinfectants, to maintain image quality and device integrity.
Can the Vivid T8 be used in an MRI environment?
No, the Vivid T8 is explicitly labeled as MRI-unsafe. This means it should only be used in clinical settings where magnetic resonance imaging (MRI) is not performed. The presence of electronic components and potential metallic parts in the system could pose risks if exposed to MRI fields, including interference or patient injury. Always verify the environment’s safety protocols before use.
What regulatory clearance does the Vivid T8 hold in the U.S.?
The Vivid T8 is authorized for commercial distribution in the United States under FDA 510(k) clearance with the designation K160078. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, meeting regulatory standards for diagnostic ultrasound systems. The clearance was granted by the FDA’s Radiology (RA) advisory committee after review.