Model: 1000-0022
DI: B225100000220
Status: New
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
Image-Intensified Fluoroscopic X-Ray, Mobile
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
23d8ca04-437b-4691-b90a-95d8b2ff7b8e
Distribution Status:
In Commercial Distribution
DUNS Number:
196554021
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:
B225100000220
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 37649
Name: Portable general-purpose fluoroscopic x-ray system, digital
Definition:
A portable (moveable from one location to another, and easily reassembled) general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium.
FDA Product Codes
OXO
Image-Intensified Fluoroscopic X-Ray System, Mobile
JAA
System, X-Ray, Fluoroscopic, Image-Intensified
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
HRX
Arthroscope
GCJ
Laparoscope, General & Plastic Surgery
Premarket Submissions
Submission Number:
K252579
Supplement Number:
000