Cleared Traditional

K052545 - INFINITT G3 PACS

K052545 is the FDA 510(k) clearance for INFINITT G3 PACS by Infinitt Co., Ltd.. It is a Class 2 Radiology device (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

Submission Details

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
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.

Device Classification

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 1097
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K052545.
VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE
K052632 · Vital Images, Inc. · Dec 2005
SYNGO DYNAMICS, VERSION 5.0
K053133 · Siemens Medical Solutions USA, Inc. · Dec 2005
ENCOMPASS SOFTWARE PACKAGE
K053043 · Toshiba America Medical Systems, In.C · Nov 2005
ADVANTAGE WORKSTATION 4.3.
K052995 · Ge Healthcare · Nov 2005
FOURSIGHT VIEWTOOL IMAGE VIEWER
K052895 · Siemens Medical Solutions USA, Inc. · Oct 2005
21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM)
K052199 · Totoku Electric Co., Ltd. · Sep 2005