Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009715136

FEI Number

3009715136

Entity Name

SG HEALTHCARE CO LTD

City/State/Country

Moga-myeon, Icheon-si Gyeonggi, KR

Establishment Address

10, Yangnyeong-ro, Moga-myeon, Icheon-si Gyeonggi 17408, KR

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SG Healthcare Co. Ltd (Owner Number: 10046997)

Owner / Operator Contact Address

10, Yangnyeong-ro, Moga-myeon, Icheon-si, KR-41 17408, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122173

PMA Number

N/A

All Registered Proprietary Names

Jumong General Garion PXP-15/20/40HF GARION T6 JUMONG JUMONG RETRO Jumong Retro 4343A Jumong Mobile Jumong M INVICTUS JUMONG RETRO Garion

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2023-03-01
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2023-03-01
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2022-10-28
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2022-10-28
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2022-10-28
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2018-07-09
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2017-04-07
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2017-04-07
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2017-04-07
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-08-29
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-08-29
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-08-29
KPR	System, X-Ray, Stationary	Radiology	Class 2	892.1680	2014-10-30
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2014-10-30
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2018-05-16
IZL	System, X-Ray, Mobile	Radiology	Class 2	892.1720	2017-09-19
IZZ	Table, Radiographic, Non-Tilting, Powered	Radiology	Class 2	892.1980	2016-08-03
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2014-06-11
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2015-11-07

Official Correspondent

No official correspondent registered.

US Agent Details

Daniel Kamm Business: Kamm & Associates Email: fda.help.now@gmail.com Phone: (847) 3741727

Related Public Records

Same Entity

SG Healthcare Co. Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K201670	Siemens Medical Solutions USA, Inc.	YSIO X.pree	2020-10-21
K123106	Samsung Electronics Co., Ltd.	DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A	2013-06-20
K203340	Siemens Medical Solutions USA, Inc.	MULTIX Impact C	2021-01-06
K230241	Sg Healthcare Co, Ltd.	Jumong General	2023-02-23
K070563	Vidar Systems Corp.	VIDAR VISION 2000	2007-03-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2009	GE Medical Systems, LLC	2	Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
Z-0002-2015	Siemens Medical Solutions USA, Inc	2	Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Z-0003-2009	GE Medical Systems, LLC	2	Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. Intended for use in generating Tomographic images of human anatomy.
Z-0003-2015	Siemens Medical Solutions USA, Inc	2	Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
Z-0004-2015	Siemens Medical Solutions USA, Inc	2	Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including but not limited to: "Querying and retrieving patient history information and/or previous diagnosis and images from other modalities; "X-ray examinations of the urogenital area "Ultrasound examinations "Endourological interventions "Percutaneous interventions "Laparoscopy "Application of fistula "Simple procedures "Extracorporeal shock wave lithotripsy "Uroflow/urodynamics "Pediatric radiological and therapeutic applications

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009715136. Last updated year: 2026. Please use registration number 3009715136 when referencing this establishment in official correspondence.