Cleared Traditional

K041500 - STARPACS ORTHOPEDICS SYSTEM

K041500 is an FDA 510(k) clearance for STARPACS ORTHOPEDICS SYSTEM, 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 14-day FDA review.

K041500 · Infinitt Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
14d
Days
Class 2
Risk

K041500 is an FDA 510(k) clearance for the STARPACS ORTHOPEDICS SYSTEM. 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 June 21, 2004 after a review of 14 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 - K041500

510(k) Number K041500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2004
Decision Date June 21, 2004
Days to Decision 14 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
93d faster than avg
Panel avg: 107d · This submission: 14d
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

Entela, Inc.
N.E. DEVINE, JR.

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 1899
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K041500.
KINETDX
K041029 · Siemens Medi Cal Solutions, Inc. · Jul 2004
MONOCHROME LCD MONITOR, MODEL RADIFORCE G22
K041597 · Eizo Nanao Corporation · Jun 2004
COMPACS, VERSION 1.0
K041581 · Intelligent Images Srl · Jun 2004
21.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A)
K040697 · Totoku Electric Co., Ltd. · Jun 2004
MRA-CMS
K040746 · Medis Medical Imaging Systems BV · Jun 2004
IPACS ORTHO
K041366 · Realtimeimage, Inc. · Jun 2004