Imaging Engineering, LLC

FDA Regulatory Profile

Imaging Engineering, LLC appears in FDA public data with 0 recalls, 4 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 16, 2025.

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251650Insight Enhanced™ DRF (EN-1002-01)September 16, 2025
K210469Insight Agile DRFJuly 27, 2021
K200396Insight Enhanced DRF Digital Imaging SystemMarch 6, 2020
K191310Insight Essentials DRF Digital Imaging SystemJune 10, 2019