X-CUBE 50, X-CUBE 60
Alpinion Medical Systems Co., Ltd.
ALPINION MEDICAL SYSTEMS Co., Ltd.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3008950127 | 3008950127 | ALPINION MEDICAL SYSTEMS Co., Ltd. | 1 | N | 2026-01-01 | 4F, 15, Magokjungang 14-ro Gangseo-gu Seoul KR 07789 |
| 3024838922 | 3024838922 | ALPINION MEDICAL SYSTEMS CO., LTD. | 1 | N | 2026-01-01 | 4F, 16, Simin-daero 327beon-gil, Dongan-gu Anyang-si Gyeonggi KR 14055 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 131044 | 1204777043 | K223564 | X-CUBE 50, X-CUBE 60 | IYN | 2023-04-17 |
| 131044 | 1430104637 | K221093 | X-CUBE 70, X-CUBE 90 | IYN | 2022-10-14 |
| 131044 | 1288497345 | K220857 | X-CUBE 50, X-CUBE 60 | IYN | 2022-10-13 |
| 131044 | 1236330772 | K213523 | X-CUBE i8, X-CUBE i9 | IYN | 2022-01-28 |
| 131044 | 2030233514 | K211300 | X-CUBE 90 | IYN | 2021-08-09 |
| 131044 | 2060083744 | K211299 | X-CUBE 70 | IYN | 2021-08-09 |
| 131044 | 1262307751 | K200450 | X-Cube 70 | IYN | 2020-07-10 |
| 131044 | 1428270733 | K200449 | X-Cube 90 | IYN | 2020-07-10 |
| 131044 | 1350359518 | K182845 | minisono | IYN | 2018-12-27 |
| 131044 | 1970081461 | K182594 | E-CUBE i7 | IYN | 2019-01-24 |
| 131044 | 1384087682 | K181617 | E-CUBE 8 | IYN | 2018-10-11 |
| 131044 | 1921924200 | K181277 | E-CUBE 12 | IYN | 2018-09-28 |
| 131044 | 1081094323 | K172732 | E-CUBE 8 | IYN | 2017-12-14 |
| 131044 | 1313815159 | K161439 | E-CUBE 11 | IYN | 2016-09-21 |
| 131044 | 1833948537 | K153424 | E-CUBE i7 | IYN | 2016-02-26 |
| 131044 | 1147731227 | K150773 | E-CUBE 15 Diagnostic Ultrasound System | IYN | 2015-07-23 |
| 131044 | 1182292231 | K142884 | E-CUBE 12 | IYN | 2014-10-28 |
| 131044 | 1464898249 | K142733 | E-CUBE 5 | IYN | 2014-10-28 |
| 131044 | 2001345524 | K132687 | E-CUBE 7 | IYN | 2013-11-27 |
| 131044 | 1741793169 | K123611 | E-CUBE 7 | IYN | 2012-12-21 |
| 131044 | 1513837026 | K123610 | E-CUBE 15 | IYN | 2013-02-01 |
| 131044 | 1244092627 | K121937 | E-CUBE INNO | IYN | 2012-07-26 |
| 131044 | 1318137836 | K121888 | E-CUBE 15 | IYO | 2012-07-26 |
| 131044 | 1591208252 | K121729 | E-CUBE 7 | IYN | 2012-09-20 |
| 131044 | 1319217805 | K120060 | E-CUBE 9 | IYN | 2012-03-16 |
| 131044 | 1667979217 | K111864 | E-CUBE 9 | IYN | 2011-07-15 |
| 310427 | 1081094323 | ||||
| 310427 | 1147731227 | ||||
| 310427 | 1182292231 | ||||
| 310427 | 1204777043 | ||||
| 310427 | 1236330772 | ||||
| 310427 | 1262307751 | ||||
| 310427 | 1288497345 | ||||
| 310427 | 1318137836 | ||||
| 310427 | 1350359518 | ||||
| 310427 | 1384087682 | ||||
| 310427 | 1428270733 | ||||
| 310427 | 1430104637 | ||||
| 310427 | 1464898249 | ||||
| 310427 | 1513837026 | ||||
| 310427 | 1833948537 | ||||
| 310427 | 1921924200 | ||||
| 310427 | 1970081461 | ||||
| 310427 | 2030233514 | ||||
| 310427 | 2060083744 |
Product Codes Associated With Registrations#
PMN#
X-CUBE 70, X-CUBE 90
Alpinion Medical Systems Co., Ltd.
X-CUBE 50, X-CUBE 60
Alpinion Medical Systems Co., Ltd.
X-CUBE I8, X-CUBE I9
Alpinion Medical Systems Co., Ltd.
X-CUBE 90
Alpinion Medical Systems Co., Ltd.
X-CUBE 70
Alpinion Medical Systems Co., Ltd.
X-Cube 90
Alpinion Medical Systems Co., Ltd.
X-Cube 70
Alpinion Medical Systems Co., Ltd.
E-CUBE I7
Alpinion Medical Systems Co., Ltd.
Minisono
Alpinion Medical Systems Co., Ltd.
E-CUBE 8
Alpinion Medical Systems Co., Ltd.
E-CUBE 12
Alpinion Medical Systems Co., Ltd.
E-CUBE 8
ALPINION MEDICAL SYSTEMS Co., Ltd.
E-CUBE 11
ALPINION MEDICAL SYSTEMS CO., LTD.
E-CUBE I7
ALPINION MEDICAL SYSTEMS CO., LTD.
GUDID#
L8-17H
2026-05-29
L3-12H
2016-09-23
L3-8
2016-09-23
L8-17X
2016-09-23
IO3-12
2016-09-23
L3-12T
2016-09-23
IO8-17
2016-09-23
IO8-17T
2016-09-23
SC1-6H
2016-09-23
SC1-4H
2016-09-23
SC1-4HS
2016-09-23
C5-8
2016-09-23
C1-6T
2016-09-23
C5-8N
2016-09-23
C5-8NT
2016-09-23
C1-6CT
2017-12-18
SP3-8
2016-09-23
SP1-5X
2016-09-23
SPN1-5X
2016-09-23
MP1-5X
2016-09-23
SP3-8T
2016-09-23
SP1-5T
2016-09-23
E3-10H
2016-09-23
EV3-10H
2016-09-23
EC3-10H
2016-09-23
EV3-10X
2016-09-23
EC3-10X
2016-09-23
SVC1-6
2016-09-23
SVC1-6H
2016-09-23
VC1-6T
2017-12-18
TEE3-7
2016-09-23
E-CUBE - E-CUBE 5
2016-09-23
E-CUBE - E-CUBE 12
2016-09-23
E-CUBE - E-CUBE 15
2016-09-23
E-CUBE - E-CUBE i7
2016-09-23
E-CUBE - E-CUBE 8
2017-12-18
minisono - minisono L3-12
2019-01-07
minisono - minisono C1-6
2019-01-07
X-CUBE 50 - The X-CUBE 50 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate).And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode.The X-CUBE 50 is intended to be used in a hospital or medical clinic.
2022-11-01
X-CUBE 60 - The X-CUBE 60 diagnostic ultrasound system is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-rectal; Trans-vaginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Peripheral Vessel(PV); and Urology(including prostate).And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Color M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode; 3D/4D mode.The X-CUBE 60 is intended to be used in a hospital or medical clinic.
2022-11-01