Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W— 510(k) K201004

Name: FDA 510(k) clearance K201004
Creator: U.S. Food and Drug Administration
Published: 2020-05-01

Substantially Equivalent

Iray Technology Taicang , Ltd.

FDA 510(k) clearance K201004 for Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W, Substantially Equivalent on 2020-05-01. Applicant: Iray Technology Taicang , Ltd.. Device class: 2.

Clearance details

Applicant: Iray Technology Taicang , Ltd.
Product code: Code MQB
Device class: Class 2
Regulation: 21 CFR 892.1680
Advisory panel: Radiology
Date received: 2020-04-16
Decision date: 2020-05-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Taicang, CN

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 Iray Technology Taicang , Ltd.

view all

K223010 — Portable X-ray System2023-01-17
K222886 — Mercu 1717V2022-10-20
K221714 — Flat Panel Detector2022-06-29
K221345 — Wireless Digital Flat Panel Detector2022-06-16
K220536 — Digital flat panel detector2022-04-28

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