Cleared Traditional

Yushan X-Ray Flat Panel Detector

K243171 · Innocare Optoelectronics Corp. · Radiology
Dec 2024
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K243171 is an FDA 510(k) clearance for the Yushan X-Ray Flat Panel Detector, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Innocare Optoelectronics Corp. (Tainan, TW). The FDA issued a Cleared decision on December 19, 2024, 80 days after receiving the submission on September 30, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K243171 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2024
Decision Date December 19, 2024
Days to Decision 80 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