FDA 510(k) clearance · back to tracker

Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System

Canon Medical Systems Corporation cleared K253597 on 2026-01-20, decision: substantially equivalent

K-number

K253597

Sponsor

Canon Medical Systems Corporation

Device

Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-01-20

Product code

IYN

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1550

Official FDA record

Open K253597on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.