Sonoline Lx
by Siemens Medical Solutions USA, Inc.
510(k) K853946
Sonoline Lx is a medical device (FDA Class II; FDA product code IYO, System, Imaging, Pulsed Echo, Ultrasonic) made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K853946 on 16 Jan 1986, 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 | NumberK853946 | Date16 Jan 1986 | StatusActive |
Official records
- FDA 510(k) database K853946
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYO
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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