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Multi Format Video Imager 600 Plus

by International Imaging Electronics

510(k) K904363

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 NumberK904363 Date13 Nov 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  • Withdrawn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, 1 Oct 2026

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

The Multi Format Video Imager 600 Plus is a Camera, Multi Format, Radiological device. It is classified as a Class 2 medical device. The device is used in the field of Radiology.

The device is supplied by International Imaging Electronics and has been cleared under the FDA 510(k) number K904363. It is a substantially equivalent device, as determined by the FDA. The device has a product code of LMC and is regulated under the regulation number 892.2040.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What is the Multi Format Video Imager 600 Plus used for?

    The Multi Format Video Imager 600 Plus is used in the field of Radiology, indicating its application in medical imaging and diagnostics, helping clinicians to visualize and assess patient conditions.

  • Is the Multi Format Video Imager 600 Plus a single-use or reusable device?

    The device description does not explicitly state whether it is single-use or reusable, suggesting that its usage may depend on specific clinical protocols or manufacturer guidelines.

  • What regulatory clearance does the Multi Format Video Imager 600 Plus have?

    The Multi Format Video Imager 600 Plus has been cleared under the FDA 510(k) number K904363, indicating that it has been determined to be substantially equivalent to a predicate device by the FDA.