Cleared Special

TrueFit Bolus; TrueFlex Bolus

K243057 · Adaptiiv Medical Technologies, Inc. · Radiology
Oct 2024
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K243057 is an FDA 510(k) clearance for the TrueFit Bolus; TrueFlex 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 October 23, 2024, 26 days after receiving the submission on September 27, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K243057 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 2024
Decision Date October 23, 2024
Days to Decision 26 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