Large Screen CRT Display 1311B

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K801000 ↗

FDA Product Code

DXJ

Device Class

Class II

Regulation

21 CFR Part 870.2450

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What types of clinical environments is this display intended for, and how is it typically used?

  The Large Screen CRT Display #1311B is designed for medical and research settings where graphical data visualization is critical. It is intended for standalone use or integration into OEM systems, particularly in cardiovascular applications. The analog voltage inputs for X, Y, and Z-axis controls allow precise graphical output, making it suitable for diagnostic imaging, monitoring, and research where clear visualization of waveforms or other graphical data is essential.

• Is this device reusable or single-use, and what are the sterility and cleaning requirements?

  The Large Screen CRT Display #1311B is supplied as a reusable, non-sterile device. Since it is not intended for sterile procedures, it should be cleaned and maintained according to standard electronic equipment guidelines to ensure proper functionality and hygiene in clinical environments. Reuse is permitted as long as the device remains in good working condition.

• What regulatory pathway was followed for this device, and what does that mean for its use?

  This device was authorized through the FDA’s 510(k) clearance process (K801000), specifically under the Traditional pathway, and is classified as Class II. It was determined to be substantially equivalent to a predicate device and is authorized for cardiovascular applications. This means it meets FDA standards for safety and effectiveness in its intended use, though it does not imply approval for all medical applications—only those aligned with its authorized classification.

• How should this display be stored, and are there any special handling instructions?

  The Large Screen CRT Display #1311B should be stored following standard guidelines for electronic equipment. This includes protecting it from physical damage, extreme temperatures, humidity, and electrostatic discharge. Since it is reusable and non-sterile, storage areas should be clean and free from contaminants to maintain its performance and longevity in clinical or research settings.