Cleared Special

TrueFit Bolus

K260308 · Adaptiiv Medical Technologies, Inc. · Radiology
Feb 2026
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K260308 is an FDA 510(k) clearance for the TrueFit Bolus, a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by Adaptiiv Medical Technologies, Inc. (Halifax, CA). The FDA issued a Cleared decision on February 19, 2026, 20 days after receiving the submission on January 30, 2026. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K260308 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2026
Decision Date February 19, 2026
Days to Decision 20 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUJ — System, Planning, Radiation Therapy Treatment
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050