Cleared Traditional

Solid State X-ray Imager(Model: FXRD-4386WB)

K220239 · Vieworks Co., Ltd. · Radiology
Sep 2022
Decision
228d
Days
Class 2
Risk

About This 510(k) Submission

K220239 is an FDA 510(k) clearance for the Solid State X-ray Imager(Model: FXRD-4386WB), a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Vieworks Co., Ltd. (Anyang-Si, KR). The FDA issued a Cleared decision on September 13, 2022, 228 days after receiving the submission on January 28, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K220239 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 2022
Decision Date September 13, 2022
Days to Decision 228 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

Similar Devices — MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 420
Lux HD 2530 detector (Lux HD 2530)
K252911 · Iray Imaging Technology (Haining) Limited · Oct 2025
Yushan X-Ray Flat Panel Detector
K250211 · Innocare Optoelectronics Corp. · Jul 2025
SKR 3000
K250665 · Konica Minolta, Inc. · Jun 2025
Wireless/ Wired X-Ray Flat Panel Detectors
K243734 · Allengers Medical Systems Limited · Apr 2025
EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG
K242770 · DRTECH Corporation · Mar 2025
EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP
K243443 · DRTECH Corporation · Mar 2025