DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA— 510(k) K113630

Name: FDA 510(k) clearance K113630
Creator: U.S. Food and Drug Administration
Published: 2011-12-29

Substantially Equivalent

Rayence Co., Ltd.

FDA 510(k) clearance K113630 for DIGITAL FLAT PANEL X-RAY DETECTOR/1210SGA, Substantially Equivalent on 2011-12-29. Applicant: Rayence Co., Ltd.. Device class: 2.

Clearance details

Applicant: Rayence Co., Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2011-12-08
Decision date: 2011-12-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MQB

view all

K253800 — 0909FCE, 0909FCE-HS2026-07-31
K260820 — VIVIX-S 4386W (FXRD-4386WA)2026-06-18
K252996 — Universal 1417PI2026-06-12
K252911 — Lux HD 2530 detector (Lux HD 2530)2025-10-09
K250211 — Yushan X-Ray Flat Panel Detector2025-07-22

More clearances from Rayence Co., Ltd.

view all

K243849 — 2430TCA with Xmaru W2025-03-12
K242394 — Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)2024-09-09
K240371 — 0909FCC, 0909FCC-HS2024-03-07
K231467 — 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF2023-06-21
K220689 — Vatech Clismile2022-05-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.