Digital Intraoral X-ray Imaging System— 510(k) K212279

Name: FDA 510(k) clearance K212279
Creator: U.S. Food and Drug Administration
Published: 2021-10-07

Substantially Equivalent

Iray Technology Taicang , Ltd.

FDA 510(k) clearance K212279 for Digital Intraoral X-ray Imaging System, Substantially Equivalent on 2021-10-07. Applicant: Iray Technology Taicang , Ltd.. Device class: 2.

Clearance details

Applicant: Iray Technology Taicang , Ltd.
Product code: Code MUH
Device class: Class 2
Regulation: 21 CFR 872.1800
Advisory panel: Dental
Date received: 2021-07-20
Decision date: 2021-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taicang, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code MUH

view all

K251793 — SOTA Cloud Smart Sensor (1.5)2026-03-03
K252570 — EzSensor HD, EzSensor UHD2025-11-10
K250687 — Cocoon Solo (DX-7020s)2025-10-24
K251206 — Digital X-Ray DentiMax Pro Imaging System2025-09-24
K240040 — VistaPano S Ceph 2.0 (VistaPano S Ceph) +3 more2024-10-25

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.