FDA.reportPublic FDA data

Insight Enhanced DRF

Primary DI
00860001668612
Brand
Insight Enhanced DRF
Company
Imaging Engineering, LLC
Model
Insight Enhanced DRF
Catalog number
EN-1000-01
Device description
Fluoroscopic imaging chain designed for GE Legacy RF, GE P500 and OEC systems.
Published
2026-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAASystem, X-Ray, Fluoroscopic, Image-Intensified
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAASystem, X-Ray, Fluoroscopic, Image-IntensifiedRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001668612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001668612008600016686128600016686120860001668612

GMDN Terms#

Term, Definition table
TermDefinition
Stationary basic diagnostic x-ray system, digitalAn assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Contacts#

Phone, Email table
PhoneEmail
239.223.1371support@imagingengineeringllc.com

Regulatory Flags#

DUNS number
096608346
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001668605Insight Essentials DRFInsight Essentials DRFES-1000-012026-05-21
00860001668636Insight Agile DRFInsight Agile DRFIA-1000-012026-05-21

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Primary DI, Brand, Company table
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00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
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00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
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