Cleared Traditional

ADD

K203188 · H&abyz Co., Ltd. · Radiology
Mar 2021
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K203188 is an FDA 510(k) clearance for the ADD, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by H&abyz Co., Ltd. (Yongin-Si, KR). The FDA issued a Cleared decision on March 12, 2021, 136 days after receiving the submission on October 27, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K203188 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 2020
Decision Date March 12, 2021
Days to Decision 136 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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