SIVR56-T KIT

• K Number: K133994
• Device Name: SIVR56-T KIT
• Manufacturer: BARCO N.V.
• Date Cleared: 2014-12-01 ( 340 days)
• Product Code: DXJ
• Regulation Number: 870.2450
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The SIVR56-T KIT is intended to be used by healthcare professionals to integrate the video from various commercially available instruments commonly used in a medical procedure into a single video display.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted for the SIVR56-T KIT.

The document is an FDA 510(k) clearance letter for the SIVR56-T Kit, classifying it as substantially equivalent to a predicate device. It specifies the regulation number (21 CFR 870.2450) and regulatory class (Class II) for a medical cathode-ray tube display. It also includes the "Indications for Use" statement, which describes the device's purpose: "The SIVR56-T KIT is intended to be used by healthcare professionals to integrate the video from various commercially available instruments commonly used in a medical procedure into a single video display."

The document discusses regulatory compliance, labeling, and reporting requirements, but does not contain any data, studies, or acceptance criteria related to the device's performance.

Regulation Number and Section

§ 870.2450 Medical cathode-ray tube display.

(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).