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
FDA 510(k) clearance K252018 · decided 2026-01-05
Clearance details
- K-number
- K252018
- Device name
- 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
- Applicant
- Samsung Medison Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-30
- Decision date
- 2026-01-05
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hongcheon-Gun, KR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Venue Go (K261668) | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC | 2026-08-07 |
| Alturion Series Diagnostic Ultrasound System (K262311) | Philips Ultrasound, LLC | 2026-08-04 |
| LOGIQ Focus (K261835) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026-07-30 |
| Handheld Ultrasound Scanner (K261288) | IMGFAX CO., LTD. | 2026-07-30 |
| 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; (K261412) | Samsung Medison Co., Ltd. | 2026-07-28 |
| Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System (K261211) | Philips Ultrasound, LLC | 2026-07-27 |
| Pocket Ultrasound System (C10MTpro,C10MXpro,C10MSpro,C10MBpro,C10MRpro) (K261081) | Beijing Konted Medical Technology Co.,Ltd | 2026-07-23 |
| ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system (K261272) | Esonic Technology (Wuhan) Co., Ltd. | 2026-07-23 |
| Alturion Series Diagnostic Ultrasound System (K260667) | Philips Ultrasound, LLC | 2026-06-29 |
| ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System (K260844) | Siemens Medical Solutions USA, Inc. | 2026-06-16 |
| ES-Series (K260748) | E-Scopics | 2026-06-09 |
| EPIQ Series Diagnostic Ultrasound System (K260123) | Philips Ultrasound, LLC | 2026-05-27 |
Recalls involving this device
No recalls on record reference this clearance.