ARIETTA Precision
ARIETTA Precision is a Class II device made by Fujifilm Corporation, cleared under FDA 510(k) K163505 on 30 May 2017 and listed in FDA GUDID since 14 Jul 2021 (UDI-DI 04573596214114), active as of 21 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 | Number04573596214114 | Date14 Jul 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163505 | Date30 May 2017 | StatusActive |
Official records
- AccessGUDID record 04573596214114
- FDA 510(k) database K163505
Across registries
- FDA 510(k) K163505 decided 30 May 2017 Active
- FDA GUDID UDI-DI 04573596214114 listed 14 Jul 2021 Listed
Timeline
- Cleared FDA 510(k) K163505
- Listed FDA GUDID 04573596214114
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- General-purpose ultrasound imaging system
- Model / reference
- ARIETTA Precision
- Primary DI / UDI-DI
- 04573596214114
- 510(k) Number
- FDA product code
- IYO, IYN, ITN
- GMDN term
- General-purpose ultrasound imaging system
- Device class
- Class II
- Regulation number
- 892.1560, 892.1550, 890.3675
- GUDID distribution status
- In Commercial Distribution
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