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Ziosoft, Inc.

FDA Regulatory Profile

Ziosoft, Inc. has 0 FDA recalls, 1 inspection, 6 510(k) clearances and 0 compliance actions on record.

Latest inspection
Dec 18, 2025 · VAI
Latest 510(k)
May 5, 2020

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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) clearances6Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Dec 18, 2025Minato, JapanDevicesVoluntary Action Indicated (VAI)3006621332

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
K200315Ziostation2May 5, 2020
K181892Ziostation2Oct 9, 2018
K091262MR CARDIAC FUNCTION ANALYSISJun 29, 2009
K083446CARDIAC FUNCTION ANALYSIS, CALCIUM SCORINGMar 31, 2009
K083084CT BRAIN PERFUSION FOR ZIOSTATIONDec 19, 2008
K070205ZIOSTATIONMar 23, 2007

FDA data resources