Cleared Traditional

K063221 - MEDWEB ADVANCED 3D WEB PACS

K063221 is an FDA 510(k) clearance for MEDWEB ADVANCED 3D WEB PACS, manufactured by Nexsys Electronics, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K063221 · Nexsys Electronics, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
49d
Days
Class 2
Risk

K063221 is an FDA 510(k) clearance for the MEDWEB ADVANCED 3D WEB PACS. 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 Nexsys Electronics, Inc. (San Leandro, US). The FDA issued a Cleared decision on December 12, 2006 after a review of 49 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 - K063221

510(k) Number K063221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2006
Decision Date December 12, 2006
Days to Decision 49 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
58d faster than avg
Panel avg: 107d · This submission: 49d
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 2284
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K063221.
NIO FUSION 4MP
K062905 · Barcoview · Dec 2006
CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY
K063628 · Ge Healthcare Integrated IT Solutions · Dec 2006
2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC
K063579 · Chi Lin Technology Co., Ltd. · Dec 2006
RCHIVE PACS
K063253 · Sobha Renaissance Information Technology Pvt, Ltd. · Dec 2006
OPAL-RAD
K063337 · Viztek, Inc. · Dec 2006
IMCO-STAT
K063392 · Imco Technologies · Dec 2006
K063221 · MEDWEB ADVANCED 3D WEB PACS
Download PDF FDA Summary Nexsys Electronics, I…