Acuson
by Siemens Medical Solutions USA, Inc. 4 variants
510(k) K131164
Acuson is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K131164 on 24 Dec 2013, 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 | NumberK131164 | Date24 Dec 2013 | StatusActive |
Official records
- FDA 510(k) database K131164
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYN
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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