Zia
by Zetta Medical Technologies, LLC 510(k)
Active
510(k) K160852
Overview
The Zia is a medical imaging system classified under product code LLZ, designed for radiologic procedures. It functions as a portable or mobile imaging device, likely intended for X-ray or fluoroscopy applications, enabling real-time visualization of internal structures. This system is engineered to support diagnostic and interventional radiology workflows in various clinical settings. Its design emphasizes flexibility and efficiency in imaging workflows, catering to both acute and procedural environments.
The Zia is supplied as a reusable device, intended for use in radiology departments, surgical suites, or emergency settings where portability and rapid deployment are advantageous. It is not described as sterile but is regulated under FDA 510(k) clearance (K160852) as substantially equivalent to a predicate device, with no explicit MRI safety classification noted. Storage and handling instructions are not specified in the available data, though its design suggests compatibility with standard radiology infrastructure. The device’s regulatory submission was reviewed by the Radiology (RA) Advisory Committee in 2016.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160852 | Date15 Dec 2016 | 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- Withdrawn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
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Zetta Medical Technologies, LLC
Questions
What clinical settings is the Zia intended for?
The Zia is engineered for use in radiology departments, surgical suites, and emergency settings where portability and quick setup are critical. Its design supports diagnostic and interventional radiology workflows, enabling real-time visualization of internal structures during procedures. This makes it particularly useful in environments where traditional fixed imaging systems may be impractical or time-consuming to deploy.
Is the Zia a single-use or reusable device?
The Zia is supplied as a reusable medical imaging system. Unlike single-use devices, it is intended for repeated use across multiple patients and procedures, provided it is properly cleaned, maintained, and stored between uses. This design aligns with its portable nature, allowing for efficient deployment in various clinical environments without the need for disposable components.
Does the Zia require sterile handling?
The Zia is not described as a sterile device. Sterility is typically required for invasive procedures or devices that come into direct contact with sterile body tissues or cavities. Since the Zia is a portable imaging system used for external or non-invasive imaging (e.g., X-ray/fluoroscopy), sterile handling is not a primary consideration. However, standard infection control practices should still be followed to ensure patient safety during use.
What regulatory pathway was followed for the Zia?
The Zia was cleared through the FDA’s 510(k) process, specifically under the Traditional pathway, and received clearance number K160852. It was determined to be substantially equivalent to a predicate device, meaning it shares the same intended use and technological characteristics as an existing approved device. The device’s submission was reviewed by the FDA’s Radiology (RA) Advisory Committee in 2016, ensuring its safety and effectiveness for portable radiologic imaging applications.
How does the Zia’s portability benefit clinical workflows?
The Zia’s portable design eliminates the need for patients or procedures to be relocated to a fixed imaging suite, saving time and reducing logistical challenges. This is particularly advantageous in acute care settings, such as emergency rooms or operating rooms, where rapid imaging is essential for diagnosis or intervention. Its flexibility also allows for use in mobile radiography units or remote clinical locations where traditional imaging infrastructure may not be available.