Skip to content

Amicas Light Beam Workstation Model 1.0

by Amicas, Inc.

510(k) K022970

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 NumberK022970 Date22 Nov 2002ClearedStatusActive

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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
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 Amicas Light Beam Workstation Model 1.0 is a Class II X-ray system designed for diagnostic imaging interpretation. It functions as a workstation for viewing and analyzing images acquired from various medical imaging modalities, including CT, MR, CR, DR, and US, adhering to DICOM standards for compatibility.

This device operates within radiology settings and is supplied as a standalone workstation requiring installation on commercial-standard hardware. Cleared under FDA 510(k) with K-number K022970 in 2002, it is intended for networked use with AMICAS servers or direct CD input, supporting lossless image transmission. No sterility or single-use specifications are noted; regulatory compliance is tied to its traditional clearance under product code LLZ.

Other devices from Amicas, Inc.