Company ยท KR
Alpinion Medical Systems Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2023. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 17, 2023 | K223564 | X-CUBE 50, X-CUBE 60 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Oct 14, 2022 | K221093 | X-CUBE 70, X-CUBE 90 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Oct 13, 2022 | K220857 | X-CUBE 50, X-CUBE 60 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Jan 28, 2022 | K213523 | X-CUBE i8, X-CUBE i9 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Aug 9, 2021 | K211300 | X-CUBE 90 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Aug 9, 2021 | K211299 | X-CUBE 70 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Jul 10, 2020 | K200450 | X-Cube 70 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Jul 10, 2020 | K200449 | X-Cube 90 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Jan 24, 2019 | K182594 | E-CUBE i7 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Dec 27, 2018 | K182845 | minisono Alpinion Medical Systems Co., Ltd., KR | IYN |
| Oct 11, 2018 | K181617 | E-CUBE 8 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Sep 28, 2018 | K181277 | E-CUBE 12 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Dec 14, 2017 | K172732 | E-CUBE 8 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Sep 21, 2016 | K161439 | E-CUBE 11 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Feb 26, 2016 | K153424 | E-CUBE i7 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Jul 23, 2015 | K150773 | E-CUBE 15 Diagnostic Ultrasound System Alpinion Medical Systems Co., Ltd., KR | IYN |
| Oct 28, 2014 | K142884 | E-CUBE 12 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Oct 28, 2014 | K142733 | E-CUBE 5 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Nov 27, 2013 | K132687 | E-CUBE 7 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Feb 1, 2013 | K123610 | E-CUBE 15 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Dec 21, 2012 | K123611 | E-CUBE 7 Alpinion Medical Systems Co., Ltd., KR | IYN |
| Sep 20, 2012 | K121729 | E-CUBE 7 Alpinion Medical Systems Co., Ltd. | IYN |
| Jul 26, 2012 | K121937 | E-CUBE INNO Alpinion Medical Systems Co., Ltd., KR | IYN |
| Jul 26, 2012 | K121888 | E-CUBE 15 Alpinion Medical Systems Co., Ltd., KR | IYO |
| Mar 16, 2012 | K120060 | E-CUBE 9 Alpinion Medical Systems Co., Ltd. | IYN |
| Jul 15, 2011 | K111864 | E-CUBE 9 Alpinion Medical Systems Co., Ltd. | IYN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||