Cleared Traditional

K082706 - INFINITT CARDIOLOGY PACS

K082706 is an FDA 510(k) clearance for INFINITT CARDIOLOGY PACS, manufactured by Infinitt Co., Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K082706 · Infinitt Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
51d
Days
Class 2
Risk

K082706 is an FDA 510(k) clearance for the INFINITT CARDIOLOGY 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 Infinitt Co., Ltd. (Denton, US). The FDA issued a Cleared decision on November 6, 2008 after a review of 51 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 - K082706

510(k) Number K082706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2008
Decision Date November 06, 2008
Days to Decision 51 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 107d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2293
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K082706.
INFINITT XELIS
K082990 · Infinitt Co., Ltd. · Nov 2008
SYNGO IMAGING XS
K082430 · Siemens AG Medical Solutions · Nov 2008
CENTRICITY PACS WEB DIAGNOSTIC
K083018 · Ge Healthcare Dynamic Imaging Solutions · Nov 2008
MEDICAL DISPLAY, MD205MG-1
K082493 · Nec Display Solutions , Ltd. · Oct 2008
SHOWCASE
K082135 · Trillium Technology, Inc. · Oct 2008
XR-EXPRESS
K082336 · New Mexico Software, Inc. · Oct 2008
K082706 · INFINITT CARDIOLOGY PACS
Download PDF FDA Summary Infinitt Co., Ltd.