Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System
FDA 510(k) clearance K251853 · decided 2025-11-07
Clearance details
- K-number
- K251853
- Device name
- Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-17
- Decision date
- 2025-11-07
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Shenzhen, CN
- 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.