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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
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.

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 Consultant

Underwriters Laboratories, Inc.
DENISE LEUNG KLINKER

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 - OEB Lung Computed Tomography System, Computer-aided Detection

All 19
Devices cleared under the same product code (OEB) and FDA review panel - the closest regulatory comparables to K041380.
SYNGO LUNG CAD
K063877 · Siemens Medical Solutions USA, Inc. · Oct 2006
ADVANCED LUNG ANALYSIS II
K042694 · GE Medical Systems · Nov 2004
LUNG CAR 1.1
K041807 · Medicsight · Jul 2004
MEDICLUNG, RELEASE 1
K033412 · Medicsight · Dec 2003
LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
K033374 · Siemens AG Medical Solutions · Nov 2003
K041380 · IMAGECHECKER-CT SOFTWARE PACKAGE WITH FILLING DEFECT INDICATOR
Download PDF FDA Summary R2 Technology, Inc.