Alpinion Medical Systems Co., Ltd.
Alpinion Medical Systems Co., Ltd. has 0 FDA recalls, 1 inspection, 26 510(k) clearances and 0 compliance actions on record.
- Latest inspection
- Mar 15, 2013 · NAI
- Latest 510(k)
- Apr 17, 2023
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Summary
- Recalls
- 0
- 510(k) Clearances
- 26
- Inspections
- 1
- Compliance Actions
- 0
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 15, 2013 | Dongan, Anyang, Korea (The Republic Of) | Devices | No Action Indicated (NAI) | 3008950127 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K223564 | X-CUBE 50, X-CUBE 60 | Apr 17, 2023 |
| K221093 | X-CUBE 70, X-CUBE 90 | Oct 14, 2022 |
| K220857 | X-CUBE 50, X-CUBE 60 | Oct 13, 2022 |
| K213523 | X-CUBE i8, X-CUBE i9 | Jan 28, 2022 |
| K211300 | X-CUBE 90 | Aug 9, 2021 |
| K211299 | X-CUBE 70 | Aug 9, 2021 |
| K200450 | X-Cube 70 | Jul 10, 2020 |
| K200449 | X-Cube 90 | Jul 10, 2020 |
| K182594 | E-CUBE i7 | Jan 24, 2019 |
| K182845 | minisono | Dec 27, 2018 |
| K181617 | E-CUBE 8 | Oct 11, 2018 |
| K181277 | E-CUBE 12 | Sep 28, 2018 |
| K172732 | E-CUBE 8 | Dec 14, 2017 |
| K161439 | E-CUBE 11 | Sep 21, 2016 |
| K153424 | E-CUBE i7 | Feb 26, 2016 |
| K150773 | E-CUBE 15 Diagnostic Ultrasound System | Jul 23, 2015 |
| K142884 | E-CUBE 12 | Oct 28, 2014 |
| K142733 | E-CUBE 5 | Oct 28, 2014 |
| K132687 | E-CUBE 7 | Nov 27, 2013 |
| K123610 | E-CUBE 15 | Feb 1, 2013 |