Cios Select (VA21) Flat Panel
by Siemens Medical Solutions USA, Inc. 2 variants
510(k) K210309
Cios Select (VA21) Flat Panel is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K210309 on 5 Mar 2021, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK210309 | Date5 Mar 2021 | StatusActive |
Official records
- FDA 510(k) database K210309
Recalls
-
- Ongoing Z-2240-2023
Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potentially fall off and the ingress of liquid may occur, the risk of electric shock exists (e.g., ingress of a large amount of liquid following the plexiglass dropping off, at the same time the user or operator happens to touch the liquid on the cover which is connected to the internal live parts).
Timeline
- Cleared FDA 510(k) K210309
- Recall initiated FDA recalls Z-2240-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OWB
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent