Model Forty Ultra Compact Video Imager

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

510(k) Number

K940332 ↗

FDA Product Code

LMC

Device Class

Class II

Regulation

21 CFR Part 892.2040

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• MP3000 Series II Compact Video Imager

  Class II

  FDA 510(k) K900900 Active Cleared 30 Apr 1990

• MP3000 Compact Video Imager

  Class II

  FDA 510(k) K900899 Active Cleared 30 Apr 1990

• Digital Image Acquisition System

  Class II

  FDA 510(k) K950330 Active Cleared 7 May 1996

• Model 400 Ultra Compact Video Imager

  Class II

  FDA 510(k) K904897 Active Cleared 20 Nov 1990

• MP3000 Series III Video Imager

  Class II

  FDA 510(k) K921992 Active Cleared 10 Jul 1992

• Ultra Compact Video Imager

  Class II

  FDA 510(k) K930765 Active Cleared 13 Sep 1993

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• Is the Model Forty Ultra Compact Video Imager designed for single-use or can it be reused in a clinical setting?

  The Model Forty Ultra Compact Video Imager is supplied as a reusable Class II medical instrument, meaning it is intended for repeated use in radiology departments after proper cleaning and maintenance.

• What types of radiographic images can the Model Forty Ultra Compact Video Imager capture and display?

  The device is a multi-format radiological camera, which means it is designed to capture and display various types of X-ray images commonly used in radiology, though specific formats are not detailed in the provided data.

• How is the Model Forty Ultra Compact Video Imager regulated in the United States?

  The Model Forty Ultra Compact Video Imager received FDA 510(k) clearance under K-number K940332, classified as substantially equivalent to a predicate device. This clearance was granted in 1994 and falls under the regulatory standards outlined in 892.2040.

• Does the Model Forty Ultra Compact Video Imager have any specific storage requirements mentioned in the regulatory data?

  The regulatory data for the Model Forty Ultra Compact Video Imager does not specify any particular storage requirements, such as temperature or environmental conditions, so standard medical device storage practices should be followed.

• What is the intended clinical use environment for the Model Forty Ultra Compact Video Imager?

  The device is intended for use in radiology departments to enhance diagnostic imaging workflows by providing real-time video output of X-ray images, as explicitly stated in its description.