Symbia 6.7
by Siemens Medical Solutions USA, Inc.
510(k) K200474
Symbia 6.7 is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K200474 on 20 Mar 2020, active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200474 | Date20 Mar 2020 | StatusActive |
Official records
- FDA 510(k) database K200474
Recalls
-
- Terminated Z-0893-2022
There is a quality issue with the three bolts that hold the CT balancing weights, which could create a safety issue.
-
- Terminated Z-2934-2020
This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have unintended slow motion of the detectors in specific situations which could pose a potential risk.
Timeline
- Cleared FDA 510(k) K200474
- Recall initiated FDA recalls Z-2934-2020
- Recall initiated FDA recalls Z-0893-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KPS
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1200
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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