Aquilion Exceed LB
by Canon Medical Systems Corporation
510(k) K211828
Aquilion Exceed LB is a Class II device made by Canon Medical Systems Corporation, cleared under FDA 510(k) K211828 on 10 Sep 2021, 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 | NumberK211828 | Date10 Sep 2021 | StatusActive |
Official records
- FDA 510(k) database K211828
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JAK
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1750
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K211828
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 | |||
|---|---|---|---|---|
| Aquilion Exceed LB TSX-202A | TSX-202A | 04987670104121 | — | On the market |
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