GM85
Samsung Electronics Co., Ltd.
Samsung Electronics Co., Ltd.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010300212 | 3010300212 | Samsung Electronics Co., Ltd. | 1 | N | 2026-01-01 | 129, Samsung-ro, Yeongtong-gu Suwon-si Gyeonggi KR 16677 |
| 3032116890 | 3032116890 | SAMSUNG ELECTRONICS CO., LTD. | 1 | N | 2026-01-01 | 1077, Cheonho-daero, Gangdong-gu Seoul KR 05340 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 154689 | 1154893495 | K260481 | GC85A | KPR | 2026-08-27 |
| 329712 | 1154893495 | K260481 | GC85A | KPR | 2026-08-27 |
| 154689 | 1906881419 | K242651 | GM85 | IZL | 2024-10-01 |
| 329712 | 1906881419 | K242651 | GM85 | IZL | 2024-10-01 |
| 154689 | 1630338542 | K242478 | GF85 (models GF85-3P, GF85-SP) | KPR | 2024-09-19 |
| 329712 | 1630338542 | K242478 | GF85 (models GF85-3P, GF85-SP) | KPR | 2024-09-19 |
| 154689 | 1468236769 | K222353 | GM85 | IZL | 2022-09-29 |
| 329712 | 1468236769 | K222353 | GM85 | IZL | 2022-09-29 |
| 329712 | 1765450527 | K220175 | GM85 | IZL | 2022-04-21 |
| 154689 | 1765450527 | K220175 | GM85 | IZL | 2022-04-21 |
| 154689 | 1674564649 | K201560 | Auto Lung Nodule Detection | MYN | 2021-08-31 |
| 329712 | 1674564649 | K201560 | Auto Lung Nodule Detection | MYN | 2021-08-31 |
| 154689 | 1565459604 | K182647 | GC70 | KPR | 2018-10-24 |
| 154689 | 1923382047 | K182622 | GU60A, GU60A-65 | KPR | 2018-10-23 |
| 154689 | 2071627563 | K182183 | GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A | KPR | 2018-12-07 |
| 329712 | 2071627563 | K182183 | GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A | KPR | 2018-12-07 |
| 154689 | 1067824995 | K181631 | GR40CW | MQB | 2018-07-20 |
| 329712 | 1067824995 | K181631 | GR40CW | MQB | 2018-07-20 |
| 154689 | 2058711707 | K181629 | GC85A | KPR | 2018-07-20 |
| 329712 | 2058711707 | K181629 | GC85A | KPR | 2018-07-20 |
| 154689 | 1783332630 | K181626 | Digital Diagnostic Mobile X-ray System | IZL | 2018-07-20 |
| 329712 | 1783332630 | K181626 | Digital Diagnostic Mobile X-ray System | IZL | 2018-07-20 |
| 154689 | 1616418472 | K180543 | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 | KPR | 2018-05-24 |
| 329712 | 1616418472 | K180543 | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 | KPR | 2018-05-24 |
| 154689 | 1239506234 | K173828 | GU60A & GU60A-65 | KPR | 2018-01-12 |
| 154689 | 1006842596 | K172229 | GC85A | KPR | 2017-11-22 |
| 329712 | 1006842596 | K172229 | GC85A | KPR | 2017-11-22 |
| 154689 | 2043075914 | K171119 | GM85 | IZL | 2017-05-12 |
| 329712 | 2043075914 | K171119 | GM85 | IZL | 2017-05-12 |
| 154689 | 1761156130 | K163115 | GC70 | KPR | 2016-12-07 |
| 154689 | 1749725160 | K162278 | Digital Diagnostic Mobile X-ray System | IZL | 2016-11-15 |
| 329712 | 1749725160 | K162278 | Digital Diagnostic Mobile X-ray System | IZL | 2016-11-15 |
| 154689 | 1492410685 | K160997 | GC85A | KPR | 2016-07-06 |
| 329712 | 1492410685 | K160997 | GC85A | KPR | 2016-07-06 |
| 154689 | 1861726307 | K153401 | GR40CW | MQB | 2015-12-21 |
| 329712 | 1861726307 | K153401 | GR40CW | MQB | 2015-12-21 |
| 154689 | 1328030606 | K152094 | GR40CW | MQB | 2015-10-16 |
| 329712 | 1328030606 | K152094 | GR40CW | MQB | 2015-10-16 |
| 154689 | 1636988254 | K151685 | GUA60A, GU60A-65 | KPR | 2015-07-17 |
| 154689 | 1141341918 | K151419 | GF50A | KPR | 2015-06-23 |
| 154689 | 1913326976 | K150165 | GC85A | KPR | 2015-04-02 |
| 329712 | 1913326976 | K150165 | GC85A | KPR | 2015-04-02 |
| 154689 | 1017807564 | K150097 | GM60A-32S & GM60A-40S | IZL | 2015-02-19 |
| 154689 | 1790118035 | K143029 | Digital Diagnostic X-ray System (GC80) | KPR | 2015-02-04 |
| 154689 | 1535588688 | K142492 | GM60A-32S, GM60A-40S | IZL | 2014-12-17 |
| 154689 | 1928273842 | K140334 | XGEO GC80 | KPR | 2014-05-28 |
| 154689 | 1918582760 | K140332 | XGEO GU60A | KPR | 2014-05-28 |
| 154689 | 1991203617 | K140326 | XGEO GF50 | KPR | 2014-05-29 |
| 154689 | 1220008640 | K140235 | XGEO GR40CW | MQB | 2014-05-15 |
| 329712 | 1220008640 | K140235 | XGEO GR40CW | MQB | 2014-05-15 |
| 154689 | 1268237689 | K123106 | DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A | KPR | 2013-06-20 |
| 154689 | 1460167917 | K123105 | XGEO GU60 | KPR | 2013-06-07 |
| 154689 | 2006003992 | K123098 | XGEO GC80 | KPR | 2013-01-18 |
| 154689 | 1072462893 |
Product Codes Associated With Registrations#
PMN#
GF85 (models GF85-3P, GF85-SP)
Samsung Electronics Co., Ltd.
Samsung ECG App v 1.3 (ECG)
Samsung Electronics Co., Ltd.
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
Samsung Electronics Co., Ltd.
GM85
Samsung Electronics Co., LTD.
GEMS-H
Samsung Electronics Co., Ltd.
CUBE Air Purifier
Samsung Electronics Co., Ltd.
GC70, GU60A, GU60A-65, GF50, GR50A ; GR40CW ; GM85 ; GC85A
Samsung Electronics Co., LTD.
GC70
Samsung Electronics Co., Ltd.
GU60A, GU60A-65
SAMSUNG ELECTRONICS CO., LTD.
GR40CW
Samsung Electronics Co., Ltd.
GC85A
Samsung Electronics Co., Ltd.
Digital Diagnostic Mobile X-ray System
Samsung Electronics Co., Ltd.
GC70
SAMSUNG ELECTRONICS CO., LTD.
Digital Diagnostic Mobile X-ray System
SAMSUNG ELECTRONICS CO., LTD.
GC85A
SAMSUNG ELECTRONICS CO., LTD.
GR40CW
SAMSUNG ELECTRONICS CO., LTD.
GR40CW
SAMSUNG ELECTRONICS CO., LTD.
GUA60A, GU60A-65
SAMSUNG ELECTRONICS CO., LTD.
GF50A
SAMSUNG ELECTRONICS CO., LTD.
GC85A
SAMSUNG ELECTRONICS CO., LTD.
GM60A-32S & GM60A-40S
SAMSUNG ELECTRONICS CO., LTD.
Digital Diagnostic X-ray System (GC80)
SAMSUNG ELECTRONICS CO., LTD.
GM60A-32S, GM60A-40S
SAMSUNG ELECTRONICS CO., LTD.
XGEO GF50
SAMSUNG ELECTRONICS CO., LTD.
XGEO GU60A
SAMSUNG ELECTRONICS CO., LTD.
XGEO GC80
SAMSUNG ELECTRONICS CO., LTD.
XGEO GR40CW
SAMSUNG ELECTRONICS CO., LTD.
S HEALTH
SAMSUNG ELECTRONICS CO., LTD.
DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A
SAMSUNG ELECTRONICS CO., LTD.
XGEO GU60
SAMSUNG ELECTRONICS CO., LTD.
XGEO GC80
SAMSUNG ELECTRONICS CO., LTD.
GUDID#
ECG Monitor App - Samsung Health Monitor ECG App for Wear OS
2021-08-25
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification - The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
2023-10-23
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification - The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
2023-10-23
Samsung ECG App v 1.3 (ECG) - The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
2025-06-10
Samsung ECG App v 1.3 (ECG) - The ECG Monitor App intended for adults 22 years and older analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of AFib and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The IHRN feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification. The ECG Monitor App is not intended to replace traditional methods of diagnosis or treatment. The ECG app is not intended for users with known arrhythmias other than AFib or users under 22 years old. Users should not interpret or take clinical action based on the device output without consultation of a qualified healthcare professional.
2025-06-10
ECG Monitor App - v1.1
2020-09-24
ECG Monitor App - v1.1
2020-09-24
NA - The Auto Lung Nodule Detection is computer-aided detection software to identify and mark regions in relation to suspected pulmonary nodules from 10 to 30 mm in size. It is designed to aid the physician to review the PA chest radiographs of adults as a second reader and be used as part of S-Station, which is operation software installed on Samsung Digital X-ray Imaging systems. Auto Lung Nodule Detection cannot be used on the patients who have lung lesions other than abnormal nodules.
2026-03-17
NA - The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2016-09-24
NA - The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2016-11-26
NA - The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
2019-06-19
Samsung Sleep Apnea Feature (Wear OS) - The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use.This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders
2025-02-24
Samsung Sleep Apnea Feature (Android OS) - The Sleep Apnea Feature is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone.This feature is intended to detect signs of moderate to severe obstructive sleep apnea in the form of significant breathing disruptions in adult users 22 years and older, over a two-night monitoring period. This feature is intended for on-demand use.This feature is not intended for users who have previously been diagnosed with sleep apnea. Users should not use this feature to replace traditional methods of diagnosis and treatment by a qualified clinician. The data provided by this feature are also not intended to assist clinicians in diagnosing sleep disorders.
2025-02-24
Samsung Health Body Composition - Samsung Health Body Composition tracker for android OS smart watch
2021-09-07
NA - Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2024-11-26
NA - The GF85 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2024-10-18
NA - The GF85 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2024-10-18
Samsung Health Body Composition - Samsung Health Body Composition tracker for android OS smart phone
2021-09-07
NA - Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2022-10-20
NA - Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2022-05-04
NA - Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2022-05-04
NA - The GF50 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2016-09-24
NA - The GF50A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2016-09-24
NA - The GU60A-65 Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2016-09-24
NA - The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2017-01-06
NA - Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2016-09-24
NA - The GR40CW and GR40CWD Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
2019-10-08
NA - Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2019-06-19
NA - Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2019-06-19
NA - Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2018-12-03
NA - Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2016-09-24
NA - Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2016-09-24
NA - The GR40CW and GR40CWC Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
2019-01-24
NA - The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
2016-09-24
NA - Anti-scatter X-ray Grid used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2016-11-18
NA - Anti-scatter X-ray Grid used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2016-11-18
NA - Anti-scatter X-ray Grid used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2016-11-18
NA - Anti-scatter X-ray Grid used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2016-11-18
NA - The GC80 Series Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2016-10-31
NA - Anti-scatter X-ray Grid used as part of Digital X-ray Imaging System that is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
2016-12-23