Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

See-Mode Augmented Reporting Tool, Breast (SMART-B)

K-Number: K260303 · 2026-07-28

ApplicantSee-Mode Technologies Pty, Ltd.
Decision Date2026-07-28
Product CodeQDQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

See-Mode Augmented Reporting Tool, Breast (SMART-B) is the device name listed in this FDA 510(k) record. The listed applicant is See-Mode Technologies Pty, Ltd.. It received FDA 510(k) clearance on 2026-07-28 under 510(k) number K260303. The device is classified under product code QDQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the See-Mode Augmented Reporting Tool, Breast (SMART-B)?

See-Mode Augmented Reporting Tool, Breast (SMART-B) is a medical device that received FDA 510(k) clearance on 2026-07-28. The listed applicant is See-Mode Technologies Pty, Ltd.. The 510(k) number is K260303.

When did See-Mode Augmented Reporting Tool, Breast (SMART-B) receive FDA 510(k) clearance?

See-Mode Augmented Reporting Tool, Breast (SMART-B) received FDA 510(k) clearance on 2026-07-28, under 510(k) number K260303.

Who is the listed applicant for See-Mode Augmented Reporting Tool, Breast (SMART-B)?

The FDA 510(k) record lists See-Mode Technologies Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for See-Mode Augmented Reporting Tool, Breast (SMART-B)?

The FDA product code for See-Mode Augmented Reporting Tool, Breast (SMART-B) is QDQ.

Related Devices (Code: QDQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260714MammoScreen® (5)TherapixelK253825Saige-DxDeepHealth, Inc.K253682DeepHealth ProstateAIQuantib B.V.K260320Lunit INSIGHT MMG (v1.1.10)Lunit, Inc.K253796Lunit INSIGHT DBT (V1.2)Lunit, Inc.K251474Median LCS (internal name) / eyonis LCS (trade name) (1.0)Median Technologies

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑