MP3000 Series III Video Imager

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

510(k) Number

K921992 ↗

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 Forty Ultra Compact Video Imager

  Class II

  FDA 510(k) K940332 Active Cleared 8 Jun 1994

• Model 400 Ultra Compact Video Imager

  Class II

  FDA 510(k) K904897 Active Cleared 20 Nov 1990

• Ultra Compact Video Imager

  Class II

  FDA 510(k) K930765 Active Cleared 13 Sep 1993

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• What is the MP3000 Series III Video Imager used for?

  The MP3000 Series III Video Imager is designed for capturing and displaying radiographic images in real-time within radiology settings. It enhances diagnostic imaging by providing high-quality video output of X-ray images, improving visualization for clinicians during procedures.

• Is the MP3000 Series III Video Imager single-use or reusable?

  This device is supplied as a reusable medical instrument. It is intended for repeated use in radiology environments, provided it is properly cleaned, maintained, and stored according to manufacturer guidelines.

• What regulatory clearance does the MP3000 Series III Video Imager hold?

  The MP3000 Series III Video Imager has received FDA 510(k) clearance under the product code LMC, classified as a Class II device. This clearance confirms it is substantially equivalent to a legally marketed predicate device and authorized for distribution in the United States.

• Are there multiple models or configurations for the MP3000 Series III Video Imager?

  Yes, the MP3000 Series III Video Imager includes multiple registration numbers (e.g., 3001722928, 3015276088), which may correspond to different configurations or variants within the series. These variations are documented under the same core product classification and regulatory clearance.

• Does the MP3000 Series III Video Imager require special storage or handling?

  While specific storage instructions are not detailed in the provided data, reusable medical devices like this one generally require clean, dry storage in a controlled environment to prevent contamination or damage. Follow the manufacturer’s guidelines for proper maintenance and storage to ensure optimal performance and longevity.