# Imaging Engineering, LLC

- Location (FDA's records): Cape Coral, FL
- FDA decisions: 4 (2019–2025): 4 510(k) clearances
- Product codes: JAA (4)
- 510(k) review time since 2016: median 26 days, against 49 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ge Oec Medical Systems, Inc.: 1 (https://510kreport.com/company/ge-oec-medical-systems)
- Virtual Imaging, Inc.: 1 (https://510kreport.com/company/virtual-imaging)
- Portavision Medical, LLC: 1 (https://510kreport.com/company/portavision-medical)

## Firms that cite its devices most
- Medicatech USA: 1 (https://510kreport.com/company/medicatech-usa)

## Its most-cited devices
- K191310: Insight Essentials DRF Digital Imaging System (2019), cited by 1
- K210469: Insight Agile DRF (2021), cited by 1
- K200396: Insight Enhanced DRF Digital Imaging System (2020), cited by 1

## Recent decisions
- K251650: Insight Enhanced™ DRF (EN-1002-01) (Sep 16, 2025)
- K210469: Insight Agile DRF (Jul 27, 2021)
- K200396: Insight Enhanced DRF Digital Imaging System (Mar 6, 2020)
- K191310: Insight Essentials DRF Digital Imaging System (Jun 10, 2019)

Source page: https://510kreport.com/company/imaging-engineering