Cleared Traditional

MOZI TPS

K223724 · Manteia Technologies Co., Ltd. · Radiology
Jul 2023
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K223724 is an FDA 510(k) clearance for the MOZI TPS, a System, Planning, Radiation Therapy Treatment (Class II — Special Controls, product code MUJ), submitted by Manteia Technologies Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on July 10, 2023, 209 days after receiving the submission on December 13, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K223724 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 2022
Decision Date July 10, 2023
Days to Decision 209 days
Submission Type Traditional
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