Cleared Traditional

K062477 - AMICAS VISION SERIES PACS, MODEL 4.3

K062477 is an FDA 510(k) clearance for AMICAS VISION SERIES PACS, 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 64-day FDA review.

K062477 · Amicas, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
64d
Days
Class 2
Risk

K062477 is an FDA 510(k) clearance for the AMICAS VISION SERIES PACS, MODEL 4.3. 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 October 27, 2006 after a review of 64 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.

FDA 510(k) Submission Details - K062477

510(k) Number K062477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2006
Decision Date October 27, 2006
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
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 2268
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K062477.
IMT.LAB SOFTWARE
K062598 · Esaote Europe B.V. · Oct 2006
UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0
K062743 · Electronic Business Machine Co., Ltd. (Ebm) · Oct 2006
VISTADENT OC - VERSION 4
K060836 · Dentsply Intl., Inc. · Oct 2006
VISAGE PACS/CS, RELEASE VERSION 4.1
K062490 · Mercury Computer Systems, Inc. · Oct 2006
3DNET SUITE
K063107 · Biotronics3D, Ltd. · Oct 2006
CENTARISONE RIS/PACS
K063037 · Centarisone, LLC · Oct 2006
K062477 · AMICAS VISION SERIES PACS, MODEL 4.3
Download PDF FDA Summary Amicas, Inc.