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MP3000 Series II Compact Video Imager

by International Imaging Electronics

510(k) K900900

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK900900 Date30 Apr 1990ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LMC
Device Class
Class II
Regulation
21 CFR Part 892.2040
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The MP3000 Series II Compact Video Imager is a Camera, Multi Format, Radiological device, designed for capturing radiographic images in a portable and compact form. It functions as a video-based imaging system, enabling real-time visualization of radiographic studies for diagnostic evaluation in radiology settings. The device supports multiple imaging formats, facilitating versatility in clinical applications such as fluoroscopy and other radiographic procedures.

This device is supplied as a reusable medical instrument and is intended for use in radiology departments or similar clinical environments. It is classified under FDA regulation 892.2040 and holds a 510(k) clearance (K900900) with a Substantially Equivalent (SESE) determination. The imager is not indicated for MRI use and must be stored in accordance with manufacturer guidelines to maintain functionality and sterility. No specific single-use or sterile packaging details are provided in the regulatory data.

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