FDA 510(k) clearance · back to tracker

Aquilion ONE (TSX-308A/TSX-306A) V2.0

Canon Medical Systems Corporation cleared K253596 on 2026-05-20, decision: substantially equivalent

K-number

K253596

Sponsor

Canon Medical Systems Corporation

Device

Aquilion ONE (TSX-308A/TSX-306A) V2.0

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-05-20

Product code

JAK

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1750

Official FDA record

Open K253596on accessdata.fda.gov →

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

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K253596 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

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