Sonosite MT P33000-12
Sonosite MT P33000-12 is a Class II device made by Fujifilm Sonosite, Inc., cleared under FDA 510(k) K253448 on 3 Nov 2025 and listed in FDA GUDID since 26 Oct 2026 (UDI-DI 00841517112776), active as of 9 Nov 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 | Number00841517112776 | Date26 Oct 2026 | StatusListed |
| United States | FDA 510(k) | NumberK253448 | Date3 Nov 2025 | StatusActive |
Official records
- AccessGUDID record 00841517112776
- FDA 510(k) database K253448
Across registries
- FDA 510(k) K253448 decided 3 Nov 2025 Active
- FDA GUDID UDI-DI 00841517112776 listed 26 Oct 2026 Listed
Timeline
- Cleared FDA 510(k) K253448
- Listed FDA GUDID 00841517112776
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sonosite MT
- Generic name
- Extracorporeal ultrasound imaging transducer, hand-held
- Model / Ref / Catalog
- P33000-12, P33000
- Primary DI / UDI-DI
- 00841517112776
- 510(k) Number
- FDA product code
- ITX, IYN, IYO
- GMDN term
- Extracorporeal ultrasound imaging transducer, hand-held
- Device class
- Class II
- Regulation number
- 892.1570, 892.1550, 892.1560
- GUDID distribution status
- In Commercial Distribution
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