MULTIX Impact
by Siemens Medical Solutions USA, Inc. 3 variants
510(k) K193089
MULTIX Impact is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K193089 on 20 Mar 2020, 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 | NumberK193089 | Date20 Mar 2020 | StatusActive |
Official records
- FDA 510(k) database K193089
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KPR
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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