Versana Active
by GE Medical Systems Ultrasound and Primary Care Diagnostics 510(k)
Active
510(k) K191798
Overview
The Versana Active is a portable ultrasound system designed for diagnostic imaging in radiology and primary care settings. It provides high-resolution imaging capabilities, enabling clinicians to visualize internal body structures such as organs, tissues, and blood flow for diagnostic evaluation. As a substantially equivalent device under FDA 510(k) clearance (K191798), it adheres to regulatory standards for safety and performance in medical imaging applications.
This system is intended for use in clinical environments where real-time imaging is required, supporting procedures such as musculoskeletal assessments, abdominal scans, and vascular studies. Supplied as a reusable device, it is not single-use and must be maintained according to manufacturer guidelines. The Versana Active operates within standard MRI safety parameters for non-MRI environments and is not classified for use in MRI-compatible settings. Storage and servicing are supported by GE Medical Systems Ultrasound and Primary Care Diagnostics, with a standard three-year service coverage as part of its design.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191798 | Date9 Aug 2019 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
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Questions
What clinical applications is the Versana Active designed for?
The Versana Active is specifically designed for real-time diagnostic imaging in radiology and primary care settings. It supports procedures such as musculoskeletal assessments, abdominal scans, and vascular studies, enabling clinicians to visualize internal structures like organs, tissues, and blood flow for accurate diagnostic evaluation.
Is the Versana Active a single-use or reusable device?
The Versana Active is a reusable device. It is not intended for single-use and must be maintained according to the manufacturer’s guidelines to ensure optimal performance and safety. Proper cleaning, servicing, and storage are essential to extend its operational lifespan.
What type of regulatory clearance does the Versana Active hold?
The Versana Active holds FDA 510(k) clearance under the classification of substantially equivalent devices (K191798). This clearance confirms that it meets regulatory standards for safety and performance in medical imaging applications, particularly within radiology. The device was reviewed by the Radiology Advisory Committee (RA).
Can the Versana Active be used in MRI environments?
No, the Versana Active is not designed for use in MRI-compatible environments. It operates within standard MRI safety parameters for non-MRI settings, meaning it should only be used in clinical areas where MRI procedures are not performed. Always verify the environment’s safety guidelines before use.
What support and service coverage does GE Medical Systems provide for the Versana Active?
GE Medical Systems Ultrasound and Primary Care Diagnostics offers storage and servicing support for the Versana Active. The device includes a standard three-year service coverage as part of its design, ensuring reliable maintenance and performance. For servicing inquiries, contact GE Medical Systems directly.