Asir-V
510(k) K133640
Asir-V is a Class II device made by GE Medical Systems, LLC, cleared under FDA 510(k) K133640 on 25 Mar 2014, 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 | NumberK133640 | Date25 Mar 2014 | StatusActive |
Official records
- FDA 510(k) database K133640
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- Withdrawn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 K133640
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 | |||
|---|---|---|---|---|
| ASiR-V 1.0 | 1.0 | 00840682134972 | — | On the market |
| ASiR-V 1.1 | 5869273 / 1.1 | 00195278303196 | — | On the market |
| Revolution | EVO | 00840682109796 | — | On the market |
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