Cleared Traditional

AccuCheck

K223834 · Manteia Technologies Co., Ltd. · Radiology
Jul 2023
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K223834 is an FDA 510(k) clearance for the AccuCheck, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Manteia Technologies Co., Ltd. (Xiamen, CN). The FDA issued a Cleared decision on July 20, 2023, 210 days after receiving the submission on December 22, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K223834 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2022
Decision Date July 20, 2023
Days to Decision 210 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

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