510(k)
K251853: 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) · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · decided Nov 7, 2025
Key facts
| 510(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. |
| Product code | IYN |
| Subsequent product codes | ITX, IYO |
| Date received | Jun 17, 2025 |
| Decision date | Nov 7, 2025 |
| Decision | Substantially equivalent (SESE) |
| Submission type | Traditional |
| Review panel | Radiology |
| Medical specialty | Radiology |
At a glance
- None MAUDE adverse event reports
- None Recall events
- 10–99 UDI device identifiers (GUDID)
- 1–9 Predicate devices cited
- 1–9 Later submissions citing this device
- 1,000+ 510(k)s with this product code
- Yes 510(k) summary on file
- No 510(k) statement on file
- Not listed On the FDA AI-enabled device list
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
Reading a 510(k)
- Decision
- SESE means the FDA found the device substantially equivalent to its predicate, so it may be marketed in the United States.
- Predicates
- Each clearance cites one or more legally marketed devices; the chain of predicates shows where a technology came from.
- Product code
- The three-letter code sets the device type, class and regulation, and groups competing clearances.
- Summary or statement
- Applicants file either a 510(k) summary of the safety and effectiveness information or a statement that it is available on request.
About 510(k) premarket notifications
A 510(k) is a premarket submission made to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.
Source: U.S. Food and Drug Administration (FDA), 510(k) Premarket Notification database · Source date: