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Seno Medical Instruments, Inc.

FDA Regulatory Profile

Seno Medical Instruments, Inc. has 0 FDA recalls, 2 inspections, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Mar 25, 2026 · NAI
Latest 510(k)
Mar 5, 2019

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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
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 25, 2026San Antonio, TXDevicesNo Action Indicated (NAI)3014755924
Mar 10, 2022San Antonio, TXDevicesVoluntary Action Indicated (VAI)3014755924

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
K182628Imagio Ultrasound Imaging SystemMar 5, 2019

FDA data resources