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Perimeter Medical Imaging, Inc.

FDA Regulatory Profile

Perimeter Medical Imaging, Inc. has 0 FDA recalls, 0 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Mar 26, 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) clearances3Oct 4, 2026Not statedCurrent
Inspections0Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K190404OTIS Optical Coherence Tomography SYstemMar 26, 2019
K171560OTIS Optical Coherence Tomography SystemAug 25, 2017
K160240Perimeter Otis™ 1.0 Optical Coherence Tomography SystemMay 13, 2016

FDA data resources