# Samsung Medison Co., Ltd.

- Location (FDA's records): Hongcheon-Gun, KR
- FDA decisions: 75 (2011–2026): 75 510(k) clearances
- Product codes: IYN (70), LLZ (4), IYO (1)
- 510(k) review time since 2016: median 89 days, against 105 for FDA's reviews in the same codes and years (39 of 57 faster)
- Predicates its devices cite: 190 (140 its own); citations of its devices by later devices: 150 (140 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medison Co., Ltd.: 16 (https://510kreport.com/company/medison)
- GE Healthcare: 15 (https://510kreport.com/company/ge-healthcare)
- Siemens Medical Solutions USA, Inc.: 4 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Philips Ultrasound, Inc.: 4 (https://510kreport.com/company/philips-ultrasound)
- Hitachi Aloka Medical, Ltd.: 3 (https://510kreport.com/company/hitachi-aloka-medical)
- Supersonic Imagine: 2 (https://510kreport.com/company/supersonic-imagine)
- Sonosite,Inc.: 1 (https://510kreport.com/company/sonosite)
- Advanced Technology Laboratories, Inc.: 1 (https://510kreport.com/company/advanced-technology-laboratories)

## Firms that cite its devices most
- Alpinion Medical Systems Co., Ltd.: 4 (https://510kreport.com/company/alpinion-medical-systems)
- Telemed: 3 (https://510kreport.com/company/telemed)
- Vinno Technology (Suzhou) Co.,Ltd: 1 (https://510kreport.com/company/vinno-technology-suzhou)
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-mindray-bio-medical-electronics)
- Jointvue, LLC: 1 (https://510kreport.com/company/jointvue)

## Its most-cited devices
- K151663: RS80A Diagnostic Ultrasound System (2015), cited by 7
- K130803: Ugeo H70C Diagnostic Ultrasound System (2013), cited by 6
- K112339: Accuvix A30 Diagnostic Ultrasound System (2011), cited by 6
- K153529: WS80A Diagnostic Ultrasound System (2016), cited by 6
- K112646: Sonoace R7 Diagnostic Ultrasound System (2011), cited by 5
- K143089: WS80A Diagnostic Ultrasound System (2014), cited by 5

## Recent decisions
- K263150: V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10 Diagnostic Ultrasound System; XH10 Diagnostic Ultrasound System; V10 ONE Diagnostic Ultrasound System; cV10 ONE Diagnostic Ultrasound System; H10 ONE Diagnostic Ultrasound System; XV10 ONE Diagnostic Ultrasound System; XH10 ONE Diagnostic Ultrasound System; HERA Z10 Diagnostic Ultrasound System (Oct 8, 2026)
- K263182: EVO X30 Diagnostic Ultrasound System; EVO X20 Diagnostic Ultrasound System; EVO X10 Diagnostic Ultrasound System; EVO XP30 Diagnostic Ultrasound System; EVO XP20 Diagnostic Ultrasound System; EVO XP10 Diagnostic Ultrasound System; EVO XC30 Diagnostic Ultrasound System; EVO XC20 Diagnostic Ultrasound System; EVO XC10 Diagnostic Ultrasound System (Sep 25, 2026)
- K261412: V8/XV8/XH8/H8/cV8/V8 ONE/XV8 ONE/XH8 ONE/H8 ONE/cV8 ONE Diagnostic Ultrasound System; V7/XV7/XH7/H7/cV7/V7 ONE/XV7 ONE/H7 ONE/XH7 ONE/cV7 ONE Diagnostic Ultrasound System; V6/XV6/XH6/H6/cV6/V6 ONE/XV6 ONE/H6 ONE/XH6 ONE/cV6 ONE Diagnostic Ultrasound System; V5/XV5/XH5/H5/cV5 Diagnostic Ultrasound System; V4/XV4/XH4/H4/cV4 Diagnostic Ultrasound System; (Jul 28, 2026)
- K254099: EVO Q30 Diagnostic Ultrasound System; EVO Q20 Diagnostic Ultrasound System; EVO Q10 Diagnostic Ultrasound System; EVO XQ30 Diagnostic Ultrasound System; EVO XQ20 Diagnostic Ultrasound System; EVO XQ10 Diagnostic Ultrasound System; EVO QH30 Diagnostic Ultrasound System; EVO QH20 Diagnostic Ultrasound System; EVO QH10 Diagnostic Ultrasound System (Mar 27, 2026)
- K252018: HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System (Jan 5, 2026)
- K250999: V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System; V5 Diagnostic Ultrasound System; cV5 Diagnostic Ultrasound System; V4 Diagnostic Ultrasound System; cV4 Diagnostic Ultrasound System (Jul 18, 2025)
- K243702: V8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System (Feb 12, 2025)
- K242511: V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System (Dec 10, 2024)

Source page: https://510kreport.com/company/samsung-medison