Exact Imaging, Inc.

FDA Regulatory Profile

Exact Imaging, Inc. has 0 FDA recalls, 0 inspections, 4 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Oct 1, 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) clearances4Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K192303ExactVu High Resolution Micro-Ultrasound SystemOct 1, 2019
K190995ExactVu High Resolution Micro-Ultrasound SystemMay 10, 2019
K180636ExactVu High Resolution Micro-Ultrasound SystemApr 30, 2018
K162972ExactVu High Resolution Micro-Ultrasound SystemDec 2, 2016