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Cardiovascular Imaging Technologies

FDA Regulatory Profile

Cardiovascular Imaging Technologies has 0 FDA recalls, 4 inspections, 7 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 18, 2024 · NAI
Latest 510(k)
Aug 11, 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) clearances7Oct 4, 2026Not statedCurrent
Inspections4Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 18, 2024Kansas City, MODevicesNo Action Indicated (NAI)3004504920
Oct 5, 2018Kansas City, MODevicesVoluntary Action Indicated (VAI)3004504920
Aug 8, 2013Kansas City, MODevicesNo Action Indicated (NAI)3004504920
Sep 8, 2009Kansas City, MODevicesVoluntary Action Indicated (VAI)3004504920

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
K201933ImagenSPECT 3.0Aug 11, 2020
K173547ImagenUniversalJan 12, 2018
K152503ImagenSPECTJan 25, 2016
K122241IMAGEN3DOct 24, 2012
K080770IMAGENMD WITH IMAGENQApr 9, 2008
K050366IMAGENPROMar 17, 2005
K041671IMAGENMDJul 22, 2004

FDA data resources