TrueFit Bolus
by Adaptiiv Medical Technologies Inc 2 variants
TrueFit Bolus is a Class II device made by Adaptiiv Medical Technologies Inc, cleared under FDA 510(k) K260308 on 19 Feb 2026 and listed in FDA GUDID since 24 Jun 2026 (UDI-DI 00860007402395), 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 | GUDID listing | Number00860007402395 | Date24 Jun 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK260308 | Date19 Feb 2026 | StatusActive |
Official records
- AccessGUDID record 00860007402395
- FDA 510(k) database K260308
Across registries
- FDA 510(k) K260308 decided 19 Feb 2026 Active
- FDA GUDID UDI-DI 00860007402395 listed 24 Jun 2026 Listed
Timeline
- Cleared FDA 510(k) K260308
- Listed FDA GUDID 00860007402395
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Radiation therapy bolus, reusable
- Primary DI / UDI-DI
- 00860007402395
- 510(k) Number
- FDA product code
- MUJ
- GMDN term
- Radiation therapy bolus, reusable
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code MUJ (System, Planning, Radiation Therapy Treatment).
- SAGIPLAN, SAGIPLAN PROSTATE MODULE ADD ON, SAGIPLAN INCLUDING PROSTATE MODULE by Eckert & Ziegler BEBIG GmbH
- LEKSELL GAMMAPLAN 4C WITH MULTIVIEW by Elekta Instrument AB
- PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM by Nomos Corp.
- SIMUPLAN TREATMENT PLANNING SYSTEM by Simuplan S.L.
- RayStation by RaySearch Laboratories AB (PUBL)
- P3IMRT TM by Adac Laboratories
- SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0 by Nucletron Corp.
- EQUAL DOSE by Nucletron Corp.
- MONACO RTP SYSTEM by Computerized Medical Systems, Inc.
- RADIANCE by Gmv Aerospace and Defence S.A.