FDA.reportPublic FDA data

IMAGING ENGINEERING, LLC

Matched from indexed company URL: Imaging Engineering, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30154371893015437189IMAGING ENGINEERING, LLC1N2026-01-014424 NW 13th Street Suite B-12 Gainesville FL US 32609

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860001668605Insight Essentials DRF - Fluoroscopic imaging chain designed for GE Legacy RF systems.239.223.1371support@imagingengineeringllc.com
00860001668612Insight Enhanced DRF - Fluoroscopic imaging chain designed for GE Legacy RF, GE P500 and OEC systems.239.223.1371support@imagingengineeringllc.com
00860001668636Insight Agile DRF - Fluoroscopic imaging chain designed for OEM integration.239.223.1371support@imagingengineeringllc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2287331988125183K251650Insight Enhanced™ DRF (EN-1002-01)JAA2025-09-16
2287331031923066K210469Insight Agile DRFJAA2021-07-27
2287331122508547K200396Insight Enhanced DRF Digital Imaging SystemJAA2020-03-06
2287331981865403K191310Insight Essentials DRF Digital Imaging SystemJAA2019-06-10
2287331952462256

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAA42025-09-16

PMN#

GUDID#