Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System
FDA 510(k) clearance K221496 · decided 2022-09-29
Clearance details
- K-number
- K221496
- Device name
- Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System
- Applicant
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-05-23
- Decision date
- 2022-09-29
- Days to decision
- 129 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
+ Add to Predicate Builder ◉ Watch Shenzhen Mindray Bio-Medical Electronics Co.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API,
or subscribe to weekly change alerts. Self-serve from $29/mo.
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.