TrueFit Bolus— 510(k) K260308
Substantially EquivalentAdaptiiv Medical Technologies, Inc.
FDA 510(k) clearance K260308 for TrueFit Bolus, Substantially Equivalent on 2026-02-19. Applicant: Adaptiiv Medical Technologies, Inc.. Device class: 2.
Summary
Adaptiiv Medical Technologies' TrueFit Bolus is filed under product code MUJ, radiation therapy treatment planning system. The record doesn't describe the bolus beyond its name and that code name.
Class II, 21 CFR 892.5050. Radiology is both the classification panel and the review panel, and it came in as a Special 510(k).
Adaptiiv Medical Technologies filed from Halifax, Canada. The decision came 20 calendar days after FDA received it (January 30 to February 19, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Adaptiiv Medical Technologies, Inc.
- Product code
- Product code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Halifax, CA
Recent devices under product code MUJ
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