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Modulated Imaging, Inc.

FDA Regulatory Profile

Modulated Imaging, Inc. has 0 FDA recalls, 2 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 7, 2024 · NAI
Latest 510(k)
Jul 19, 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) clearances2Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 7, 2024Costa Mesa, CADevicesNo Action Indicated (NAI)3013436077
May 24, 2019Costa Mesa, CADevicesNo Action Indicated (NAI)3013436077

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
K181623Clarifi Imaging SystemJul 19, 2018
K153426Ox-Imager CSDec 21, 2016

FDA data resources