Device
The Jumong Stationary Radiographic System is intended for use by a qualified/trained doctor or technician on both
Manufacturer
SG Healthcare Co., Ltd.
SG Healthcare Co., Ltd.
Model: Jumong
DI: 08809365280001
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
The Jumong Stationary Radiographic System is intended for use by a qualified/trained doctor or technician on both
adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest. abdomen,
extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone
or supine position. Not for mammography
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
723bc111-e3c7-49b0-8ed2-26c823804cfd
Distribution Status:
In Commercial Distribution
DUNS Number:
688442900
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:
08809365280001
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
KPR
System, X-Ray, Stationary
MQB
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Premarket Submissions
Submission Number:
K150816
Supplement Number:
000