Neuro Vision Radiographic X-Ray System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K904146 ↗

FDA Product Code

KPR

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Mallinckrodt Group, Inc. →

• What is the primary function of the Neuro Vision Radiographic X-Ray System?

  This device is a stationary X-ray system designed specifically for diagnostic imaging. It is used to produce radiographic images that assist clinicians in performing diagnostic evaluations within the field of radiology.

• What is the regulatory classification of this X-ray system?

  The Neuro Vision Radiographic X-Ray System is classified as a Class II medical device under regulation number 892.1680. It received FDA 510(k) clearance in 1990 under reference number K904146.

• Is this system intended for mobile or stationary use?

  The device is designed as a stationary X-ray system. This means it is intended to be installed in a fixed location within a clinical or radiology environment rather than being moved between patient care areas.