Biograph Horizon
by Siemens Medical Solution USA, Inc.
510(k) K193178
Biograph Horizon is a Class II device made by Siemens Medical Solution USA, Inc., cleared under FDA 510(k) K193178 on 12 Feb 2020, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK193178 | Date12 Feb 2020 | StatusActive |
Official records
- FDA 510(k) database K193178
Recalls
-
- Ongoing Z-1134-2023
This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.
Timeline
- Cleared FDA 510(k) K193178
- Recall initiated FDA recalls Z-1134-2023
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- Withdrawn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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