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Imaging Engineering, LLC: FDA-registered device maker in Gainesville, FL, United States, 3 510(k) clearances

Name: Imaging Engineering, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Imaging Engineering, LLC is registered with the FDA (registration 3015437189) in Gainesville, FL, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 16, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015437189
Address: 4424 NW 13th Street Suite B-12, Gainesville, FL, United States, 32609
Owner or operator: Imaging Engineering, LLC (10060138)
Roles: Manufacturer
First device listed: April 30, 2020
Registered through: 2026
Brand names listed: Insight Agile DRF, Insight Enhanced, Insight Enhanced DRF

Devices it lists

Device	Product code	Class	Role	Source
C-Arm Fluoroscopic X-Ray System	RCC	2	Manufacturer	accessdata.fda.gov
Image-Intensified Fluoroscopic X-Ray System, Mobile	OXO	2	Manufacturer	accessdata.fda.gov
Interventional Fluoroscopic X-Ray System	OWB	2	Manufacturer	accessdata.fda.gov
Solid State Fluoroscopic X-Ray Imager	QHY	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Fluoroscopic, Image-Intensified	JAA	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 16, 2025	K251650	Insight Enhanced DRF (EN-1002-01)	JAA	Substantially Equivalent	Imaging Engineering, LLC	accessdata.fda.gov
July 27, 2021	K210469	Insight Agile DRF	JAA	Substantially Equivalent	Imaging Engineering, LLC	accessdata.fda.gov
March 6, 2020	K200396	Insight Enhanced DRF Digital Imaging System	JAA	Substantially Equivalent	Imaging Engineering, LLC	accessdata.fda.gov

Compare with other makers

Updated September 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.