Cleared Traditional

K041380 - IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR

K041380 is an FDA 510(k) clearance for IMAGECHECKER-CT SOFTWARE PACKAGE WITH F..., manufactured by R2 Technology, Inc.. The device is a Class 2 Radiology device with product code OEB cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K041380 · R2 Technology, Inc. · Radiology device
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Jun 2004
Decision
14d
Days
Class 2
Risk

K041380 is an FDA 510(k) clearance for the IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR. Classified as Lung Computed Tomography System, Computer-aided Detection (product code OEB), Class II - Special Controls.

Submitted by R2 Technology, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on June 8, 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all R2 Technology, Inc. devices

FDA 510(k) Submission Details - K041380

510(k) Number K041380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2004
Decision Date June 08, 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
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.

OEB Device Classification - Class 2, Special Controls

Product Code OEB Lung Computed Tomography System, Computer-aided Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Assist Radiologists In The Review Of Multi-slice Computed Tomography (msct) Exams Of The Chest And Highlight Potential Nodules That The Radiologist Should Review. A Computer Aided Diagnosis, Lung Computed Tomography System Is A Class 3 Device Under Product Code Nrr.
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 - OEB Lung Computed Tomography System, Computer-aided Detection

All 16
Devices cleared under the same product code (OEB) and FDA review panel - the closest regulatory comparables to K041380.
IMAGECHECKER CT CAD SOFTWARE SYSTEM
K043617 · Hologic, Inc. · Dec 2007
SYNGO LUNG CAD
K063877 · Siemens Medical Solutions USA, Inc. · Oct 2006
ADVANCED LUNG ANALYSIS II
K042694 · GE Medical Systems · Nov 2004
LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
K033374 · Siemens AG Medical Solutions · Nov 2003