Cleared Traditional

Aquilion ServeSP (TSX-307B) V2.0

K260078 · Canon Medical Systems Corporation · Radiology
Mar 2026
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K260078 is an FDA 510(k) clearance for the Aquilion ServeSP (TSX-307B) V2.0, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Canon Medical Systems Corporation (Tustin, US). The FDA issued a Cleared decision on March 13, 2026, 60 days after receiving the submission on January 12, 2026. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K260078 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 2026
Decision Date March 13, 2026
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code JAK — System, X-ray, Tomography, Computed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750

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