Medisono
Medisono is a Class II device made by Medisono, LLC, cleared under FDA 510(k) K170303 on 19 May 2017 and listed in FDA GUDID since 24 Jan 2024 (UDI-DI B369MUS05250), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB369MUS05250 | Date24 Jan 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170303 | Date19 May 2017 | StatusActive |
Official records
- FDA 510(k) database K170303
Across registries
- FDA 510(k) K170303 decided 19 May 2017 Active
- FDA GUDID UDI-DI B369MUS05250 listed 24 Jan 2024 Listed
Timeline
- Cleared FDA 510(k) K170303
- Listed FDA GUDID B369MUS05250
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- General-purpose ultrasound imaging system
- Model / reference
- LINEAR ARRAY PROBE MODEL PB-9L-A FOR MEDISONO MS12
- Primary DI / UDI-DI
- B369MUS05250
- 510(k) Number
- FDA product code
- IYN
- GMDN term
- General-purpose ultrasound imaging system
- Device class
- Class II
- Regulation number
- 892.1550
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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