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Precision Thunis 800+

FDA 510(k)

Class II (US FDA 510(k))

510(k) K061028

by GE Medical Systems, LLC

Identifiers

510(k) Number
K061028 FDA 510(k)
FDA Product Code
JAA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1650 FDA 510(k)
Regulation Number
892.1650 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Precision Thunis 800+ is an X-Ray, Fluoroscopic, Image-Intensified System (OpenFDA: JAA), designed for generating fluoroscopic and spot-film images during diagnostic radiology procedures. It employs image-intensification technology to enhance visualization of internal anatomical structures, supporting real-time imaging for interventions such as angiography, arthrography, and other fluoroscopy-guided procedures.

This device is supplied as a reusable medical system, intended for use in radiology departments within clinical settings. It requires proper maintenance, calibration, and adherence to MRI safety guidelines (non-MRI-compatible). The Precision Thunis 800+ holds FDA 510(k) clearance (K061028) under the Abbreviated pathway, classified as a Class II radiology device (Regulation Number: 892.1650). Storage and handling must comply with manufacturer guidelines to ensure operational integrity and patient safety.

Frequently asked questions

What procedures does the Precision Thunis 800+ support during fluoroscopy?

The Precision Thunis 800+ is designed for generating fluoroscopic and spot-film images, particularly supporting real-time visualization during interventions like angiography and arthrography. Its image-intensification technology improves contrast and clarity of internal anatomical structures, making it ideal for guided procedures in radiology.

Is the Precision Thunis 800+ a single-use or reusable device?

The Precision Thunis 800+ is a reusable medical system. As a Class II radiology device, it requires regular maintenance, calibration, and adherence to manufacturer guidelines to ensure reliable performance and patient safety over repeated use.

What safety considerations must be followed when using this fluoroscopic system?

The Precision Thunis 800+ is not MRI-compatible, so strict MRI safety protocols must be followed in environments where MRI equipment is present. Additionally, proper maintenance and calibration are critical to ensure accurate imaging and device integrity.

How is the Precision Thunis 800+ regulated in the U.S.?

The Precision Thunis 800+ holds FDA 510(k) clearance (K061028) under the Abbreviated pathway, classified as a Class II radiology device (Regulation Number: 892.1650). This classification means it undergoes rigorous review to ensure safety and effectiveness before market authorization.

What storage and handling guidelines apply to this device?

Storage and handling of the Precision Thunis 800+ must comply with manufacturer-provided guidelines to preserve operational integrity. This includes protecting the system from physical damage, environmental contaminants, and ensuring proper environmental conditions (e.g., temperature, humidity) to maintain performance and sterility where applicable.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Precision Thunis 800 | GE HealthCare Service Shop USA, K061028 FDA 510 (k) - PRECISION THUNIS 800+, PRECISION THUNIS 800+ (K061028) — FDA 510 (k) | Innolitics, GE Precision Thunis 800+ | allmed.wiki, PDF GE Healthcare - accessdata.fda.gov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
GE Medical Systems, LLC

Sources (1)

  • FDA 510(k) K061028 24 fields · synced Oct 1, 2026