FDA.report

510(k) K260078

Device
Aquilion ServeSP (TSX-307B) V2.0
Applicant
Canon Medical Systems Corporation
510(k) number
K260078
Product code
JAK
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-13
Date received
2026-01-12
Regulation
892.1750
Classification name
System, X-Ray, Tomography, Computed
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Orlando Tadeo Jr
Address
2441 Michelle Dr. Tustin CA US 92780 92780

FDA Registration Numbers

Source Documents

510(k) summary PDF

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