DEVICE DETAILS
| NAME OF DEVICE | GM85 |
|---|---|
| ESTABLISHMENT NAME | LAC MEDICAL SUPPLIES SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC45645259517 |
| BRAND NAME | SAMSUNG ELECTRONIC CO., LTD |
| MEDICAL DEVICE CATEGORY | MD 1201 - Imaging devices utilising ionizing radiation |
| DEVICE GROUPING TYPE | SYSTEM |
| DEVICE DESCRIPTION | THE GM85 SYSTEM IS INTENDED TO BE USED FOR CAPTURING DIGITAL X-RAY IMAGES OF VARIOUS PARTS OF THE BODY INCLUDING THE HEAD, CHEST, SPINE, ABDOMEN, JOINTS, HANDS, FEET AND OTHER ORGANS. ITS INTENDED USE DOES NOT INCLUDE MAMMOGRAPHY. THE GM85 DIGITAL MOBILE X-RAY IMAGING SYSTEM IS USED TO TAKE AND STORE IMAGE FOR DIAGNOSIS OF PATIENTS. IT MAINLY CONSISTS OF THE X-RAY GENERATOR, DETECTOR, X-RAY TUBE, CONTROL PANEL, COLLIMATOR, MOBILE SYSTEM FOR MOVEMENT AND THE S-STATION (OPERATION SOFTWARE). |
| DEVICE INTENDED PURPOSE | THE GM85 IS INTENDED TO BE USED FOR CAPTURING DIGITAL X-RAY IMAGES OF VARIOUS PARTS OF THE BODY INCLUDING THE HEAD, CHEST, SPINE, ABDOMEN, JOINTS, HANDS, FEET, AND OTHER ORGANS BY A QUALIFIED/TRAINED DOCTOR OR TECHNICIAN. THIS DEVICE IS NOT INTENDED FOR MAMMOGRAPHIC APPLICATIONS. |
| VALIDITY DATE OF REGISTRATION | 21/06/2022 - 20/06/2027 |