ART-Plan
510(k) K232479
ART-Plan is a medical device (FDA Class II; FDA product code MUJ, System, Planning, Radiation Therapy Treatment) made by Therapanacea, cleared under FDA 510(k) K232479 on 22 Dec 2023, 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 | NumberK232479 | Date22 Dec 2023 | StatusActive |
Official records
- FDA 510(k) database K232479
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MUJ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K232479
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 | |||
|---|---|---|---|---|
| ART-Plan V2.X | V2.X | 03770019940013 | — | On the market |
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