Cleared Traditional

K260303 - See-Mode Augmented Reporting Tool

K260303 is the FDA 510(k) clearance for See-Mode Augmented Reporting Tool by See-Mode Technologies Pty, Ltd.. It is a Class 2 Radiology device (product code QDQ) cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K260303 · See-Mode Technologies Pty, Ltd. · Radiology device
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Jul 2026
Decision
179d
Days
Class 2
Risk

K260303 is an FDA 510(k) clearance for the See-Mode Augmented Reporting Tool, Breast (SMART-B). Classified as Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer (product code QDQ), Class II - Special Controls.

Submitted by See-Mode Technologies Pty, Ltd. (Melbourne, AU). The FDA issued a Cleared decision on July 28, 2026 after a review of 179 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2090 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all See-Mode Technologies Pty, Ltd. devices

Submission Details

510(k) Number K260303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2026
Decision Date July 28, 2026
Days to Decision 179 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
72d slower than avg
Panel avg: 107d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QDQ Radiological Computer Assisted Detection/diagnosis Software For Lesions Suspicious For Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2090
Definition A Radiological Computer Assisted Detection And Diagnostic Software For Suspected Lesions Is An Image Processing Device Intended To Aid In The Detection, Localization, And Characterization Of Lesions Suspicious For Cancer On Acquired Medical Images (e.g., Mammography , Mr, Ct, Ultrasound, Radiography). The Device Detects, Identifies And Characterizes Lesions Suspicious For Cancer Based On Features Or Information Extracted From The Images, And May Provide Information About The Presence, Location, And Characteristics Of The Lesion To The User. Primary Diagnostic And Patient Management Decisions Are Made By The Clinical User.
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.

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