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Scopix Laser Imager

by Enhanced Imaging Technologies, Inc. 510(k)

Active United States

510(k) K891924

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK891924 Date18 May 1989ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 19 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 Scopix Laser Imager is a Camera, Multi Format, Radiological, designed for capturing high-resolution images of radiographic films and other medical imaging media. It employs laser technology to digitize analog radiographic images, enabling digital storage, transmission, and analysis in radiology settings.

This device is intended for use in radiology departments and imaging facilities, where it is supplied as a reusable system. It operates in non-sterile environments and is classified under FDA regulation 892.2040 as a Class II device. The Scopix Laser Imager holds an FDA 510(k) clearance (K891924) with a decision of Substantially Equivalent, issued in 1989.

Other devices from Enhanced Imaging Technologies, Inc.