FDA 510(k)

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

K-Nummer: K260303 · 2026-07-28

AntragstellerSee-Mode Technologies Pty, Ltd.

Entscheidungsdatum2026-07-28

ProduktcodeQDQ

BeratungsausschussRA

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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)?

Der FDA-Produktcode für See-Mode Augmented Reporting Tool, Brust (SMART-B) ist QDQ.

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