Device
Fluoroscopic imaging chain designed for OEM integration.
Manufacturer
Imaging Engineering, LLC
Imaging Engineering, LLC
Model: Insight Agile DRF
Catalog: IA-1000-01
DI: 00860001668636
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
Fluoroscopic imaging chain designed for OEM integration.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
afe6fb14-6ca4-4538-bacc-504801de5e58
Distribution Status:
In Commercial Distribution
DUNS Number:
096608346
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860001668636
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 37645
Name: Stationary basic diagnostic x-ray system, digital
Definition:
An 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.
FDA Product Codes
JAA
System, X-Ray, Fluoroscopic, Image-Intensified
LLZ
System, Image Processing, Radiological