SmartChest
by Milvue
510(k) K232410
SmartChest is a Class II device made by Milvue, cleared under FDA 510(k) K232410 on 10 May 2024, 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 | NumberK232410 | Date10 May 2024 | StatusActive |
Official records
- FDA 510(k) database K232410
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QFM
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2080
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K232410
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 | |||
|---|---|---|---|---|
| SmartChest V2.x.x | V2.x.x | 03770024774016 | — | On the market |
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