AiORTA - Plan
by Vitaa Medical Solutions Inc.
510(k) K250337
AiORTA - Plan is a Class II device made by Vitaa Medical Solutions Inc., cleared under FDA 510(k) K250337 on 30 Oct 2025, 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 | NumberK250337 | Date30 Oct 2025 | StatusActive |
Official records
- FDA 510(k) database K250337
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QIH
- FDA applicant
- ViTAA Medical Solutions, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K250337
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| AiORTA - Plan | AiORTA - Plan | G703AIORTAPLAN0 | — | On the market |
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