Cleared Traditional

K052545 - INFINITT G3 PACS

K052545 is an FDA 510(k) clearance for INFINITT G3 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 54-day FDA review.

K052545 · Infinitt Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
54d
Days
Class 2
Risk

K052545 is an FDA 510(k) clearance for the INFINITT G3 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 8, 2005 after a review of 54 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 Infinitt Co., Ltd. devices

FDA 510(k) Submission Details - K052545

510(k) Number K052545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2005
Decision Date November 08, 2005
Days to Decision 54 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
53d faster than avg
Panel avg: 107d · This submission: 54d
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 1900
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K052545.
IMAGECAST PACS
K052618 · Idx Systems Corp. · Nov 2005
CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0
K052537 · American Medical Sales, Inc. · Nov 2005
COLOR NIO 2MP, E-2320 C
K052958 · Barcoview · Nov 2005
ADVANTAGE WORKSTATION 4.3.
K052995 · Ge Healthcare · Nov 2005
MIM 3.5 (CIRCA)
K052379 · Mimvista Corp. · Oct 2005
SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP)
K052775 · Siemens AG Medical Solutions · Oct 2005