Cleared Traditional

K022970 - AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0

K022970 is an FDA 510(k) clearance for AMICAS LIGHT BEAM WORKSTATION, manufactured by Amicas, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K022970 · Amicas, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
77d
Days
Class 2
Risk

K022970 is an FDA 510(k) clearance for the AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Amicas, Inc. (Boston, US). The FDA issued a Cleared decision on November 22, 2002 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Amicas, Inc. devices

FDA 510(k) Submission Details - K022970

510(k) Number K022970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2002
Decision Date November 22, 2002
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1339
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K022970.
Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN
K023877 · Philips Ultrasound, Inc. · Dec 2002
PHILIPS EASYVISION WORKSTATION RELEASE 6
K023137 · Philips Medical Systems North America Co. · Dec 2002
BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM
K022773 · Barco N.V. · Dec 2002
KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K023772 · Acuson Corp. · Nov 2002
CENTRICITY PACS PLUS
K023557 · GE Medical Systems · Nov 2002
PHILIPS DIGITAL IMAGING OPTION RELEASE 1
K023440 · Philips Medical Systems · Oct 2002