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Canon Medical Systems USA Inc

FDA Regulatory Profile

Canon Medical Systems USA Inc has 0 FDA recalls, 3 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Jan 16, 2018 · VAI
Latest 510(k)
Sep 14, 2018

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances1Oct 4, 2026Not statedCurrent
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 16, 2018Deerfield Beach, FLDevicesVoluntary Action Indicated (VAI)1000649926
Jan 28, 2014Deerfield Beach, FLDevicesNo Action Indicated (NAI)1000649926
Nov 4, 2011Deerfield Beach, FLDevicesVoluntary Action Indicated (VAI)1000649926

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K182223Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034ASep 14, 2018

FDA data resources