Uscan
510(k) K181574
Uscan is a Class II device made by EchoNous, Inc., cleared under FDA 510(k) K181574 on 10 Jul 2018, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK181574 | Date10 Jul 2018 | StatusActive |
Official records
- FDA 510(k) database K181574
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYO
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K181574
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| AI Station 2 P006200 | P006200 | 09353278000229 | On the market | |
| EchoNous Bladder Probe - Refurbished R005600 | R005600 | 09353278000175 | On the market | |
| EchoNous Bladder Probe P005600 | P005600 | 09353278000113 | On the market | |
| EchoNous System (Refurbished) R006210 | R006210 | 09353278000526 | On the market | |
| EchoNous System (Refurbished) R006705 | R006705 | 09353278000540 | On the market | |
| EchoNous System - Refurbished R005195 | R005195 | 09353278000168 | On the market | |
| EchoNous System P006210 | P006210 | 09353278000236 | On the market | |
| EchoNous System P006705 | P006705 | 09353278000533 | On the market | |
| Hub - Refurbished R005324 | R005324 | 09353278000199 | On the market | |
| Hub P005324 | P005324 | 09353278000069 | On the market | |
| Mobile Stand P005149 | P005149 | 09353278000052 | On the market | |
| Uscan Linear Probe P005194 | P005194 | 09353278000021 | On the market | |
| Uscan Linear Probe R005194 | R005194 | 09353278000601 | On the market | |
| Uscan Mobile Stand P005425 | P005425 | 09353278000076 | On the market | |
| Uscan Mobile Stand P006024 | P006024 | 09353278000205 | On the market | |
| Uscan System P005195 | P005195 | 09353278000038 | On the market |
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