Medisono
Medisono (MUS01034) is a Class II device made by Medisono, LLC, cleared under FDA 510(k) K221089 on 15 Sep 2022 and listed in FDA GUDID since 17 Nov 2023 (UDI-DI B369MUS01034), 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 | NumberB369MUS01034 | Date17 Nov 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK221089 | Date15 Sep 2022 | StatusActive |
Official records
- FDA 510(k) database K221089
Across registries
- FDA 510(k) K221089 decided 15 Sep 2022 Active
- FDA GUDID UDI-DI B369MUS01034 listed 17 Nov 2023 Listed
Timeline
- Cleared FDA 510(k) K221089
- Listed FDA GUDID B369MUS01034
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- General-purpose ultrasound imaging system
- Model / Ref / Catalog
- MS19 COLOR DOPPLER DIAGNOSTIC ULTRASOUND SYSTEM, MUS01034
- Primary DI / UDI-DI
- B369MUS01034
- 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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