FDA 510(k) clearance · back to tracker

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging

Canon Medical Systems Corporation cleared K251602 on 2025-10-10, decision: substantially equivalent

K-number

K251602

Sponsor

Canon Medical Systems Corporation

Device

Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-10-10

Product code

OWB

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1650

Official FDA record

Open K251602on 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.

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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.

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Source

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