# Alpinion Medical Systems Co., Ltd.

- Location (FDA's records): Seoul, KR
- FDA decisions: 26 (2011–2023): 26 510(k) clearances
- Product codes: IYN (25), IYO (1)
- 510(k) review time since 2016: median 120 days, against 85 for FDA's reviews in the same codes and years (4 of 15 faster)
- Predicates its devices cite: 49 (39 its own); citations of its devices by later devices: 39 (39 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Samsung Medison Co., Ltd.: 4 (https://510kreport.com/company/samsung-medison)
- Philips Ultrasound, Inc.: 3 (https://510kreport.com/company/philips-ultrasound)
- General Electric Co.: 2 (https://510kreport.com/company/general-electric)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)

## Its most-cited devices
- K120060: E-CUBE 9 (2012), cited by 6
- K132687: E-CUBE 7 (2013), cited by 5
- K153424: E-CUBE i7 (2016), cited by 5
- K150773: E-CUBE 15 Diagnostic Ultrasound System (2015), cited by 4
- K172732: E-CUBE 8 (2017), cited by 3
- K161439: E-CUBE 11 (2016), cited by 3

## Recent decisions
- 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)
- K200449: X-Cube 90 (Jul 10, 2020)
- K200450: X-Cube 70 (Jul 10, 2020)

Source page: https://510kreport.com/company/alpinion-medical-systems