TrueFit Bolus
by Adaptiiv Medical Technologies, Inc.
510(k) K260308
TrueFit Bolus is a medical device (FDA Class II; FDA product code MUJ, System, Planning, Radiation Therapy Treatment) made by Adaptiiv Medical Technologies, Inc., cleared under FDA 510(k) K260308 on 19 Feb 2026, 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 | NumberK260308 | Date19 Feb 2026 | StatusActive |
Official records
- FDA 510(k) database K260308
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- Withdrawn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 K260308
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 | |||
|---|---|---|---|---|
| TrueFit Bolus | N/A | 00860007402395 | — | On the market |
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