# Healcerion Co., Ltd.

- Location (FDA's records): Seoul, KR
- FDA decisions: 4 (2015–2022): 4 510(k) clearances
- Product codes: IYN (3), IYO (1)
- 510(k) review time since 2016: median 275 days, against 105 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 8 (3 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
- Clarius Mobile Health Corp.: 3 (https://510kreport.com/company/clarius-mobile-health)
- Mobisante, Inc.: 1 (https://510kreport.com/company/mobisante)
- Penrith Corporation: 1 (https://510kreport.com/company/penrith)

## Firms that cite its devices most
- Bionet Co., Ltd.: 2 (https://510kreport.com/company/bionet)
- Guangzhou Sonostar Technologies Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-sonostar-technologies)
- Fcu Co., Ltd.: 1 (https://510kreport.com/company/fcu)
- Clarius Mobile Health Corp.: 1 (https://510kreport.com/company/clarius-mobile-health)

## Its most-cited devices
- K151339: SONON Ultrasound Imaging System (Model: SONON 300C) (2015), cited by 5
- K170085: SONON Ultrasound Imaging System, Model: 300L (2017), cited by 3

## Recent decisions
- K211665: SONON Ultrasound Imaging System, Model: SONON300C (May 16, 2022)
- K212400: SONON Ultrasound Imaging System, Model: SONON 500L (Apr 22, 2022)
- K170085: SONON Ultrasound Imaging System, Model: 300L (Oct 12, 2017)
- K151339: SONON Ultrasound Imaging System (Model: SONON 300C) (Sep 10, 2015)

Source page: https://510kreport.com/company/healcerion