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Wireless Digital Flat Panel Detector Mars1417V-TSI, Wireless Digital Flat Panel Detector Mano4336W

by Iray Technology Taicang, Ltd.

510(k) K201004

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201004↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK201004 Date1 May 2020ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W
510(k) Number
FDA Product Code
MQB
FDA applicant
Iray Technology Taicang , Ltd.
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The device is a Solid State X-Ray Imager (Flat Panel/Digital Imager), designed to capture and digitise radiographic images wirelessly. It employs a flat panel detector technology to convert X-ray exposure into digital signals, enabling high-resolution imaging for diagnostic radiology applications. These detectors are integral for fluoroscopy, mammography, and general radiography, providing real-time imaging capabilities with reduced patient dose and improved workflow efficiency.

The detectors are supplied as reusable medical devices, intended for use in radiology departments within healthcare facilities. They are classified as Class II devices under FDA regulations and have received FDA 510K clearance and MDR authorisation. The devices are not single-use and require proper maintenance, calibration, and sterilisation procedures as outlined in manufacturer guidelines. Compatibility with MRI environments is not specified, and storage conditions must adhere to the manufacturer’s instructions to preserve performance and integrity.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Are these detectors compatible with MRI environments, and if not, why should I avoid using them there?

    The device specifications do not mention compatibility with MRI environments, meaning there is no explicit confirmation that these detectors are safe for use in such settings. MRI environments involve strong magnetic fields, which could potentially interfere with electronic components or pose safety risks. To ensure patient and staff safety, it is critical to follow manufacturer guidelines and avoid using these detectors in MRI environments unless explicitly approved for that purpose.

  • How are these detectors maintained, and what sterilization procedures should be followed?

    These detectors are reusable medical devices and require proper maintenance, calibration, and sterilization as outlined in the manufacturer’s guidelines. Since they are not single-use, regular cleaning and sterilization are essential to prevent contamination and ensure reliable performance. The manufacturer’s instructions should be consulted for specific sterilization protocols, such as autoclave or chemical sterilization, to maintain device integrity and functionality.

  • What types of imaging applications are these detectors designed for, and how do they improve workflow efficiency?

    The detectors are designed for fluoroscopy, mammography, and general radiography, enabling high-resolution imaging with wireless connectivity. They convert X-ray exposure into digital signals in real-time, which reduces patient radiation dose and streamlines workflow by eliminating the need for film processing. This enhances diagnostic accuracy and operational efficiency in radiology departments.

  • What regulatory pathways have these devices undergone, and what does that mean for my facility?

    These detectors have received FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming they meet regulatory standards for safety and effectiveness. The FDA classification is Class II, indicating moderate risk, and the clearance was granted under a Special 510(k) pathway. This means your facility can procure them with confidence, knowing they comply with stringent regulatory requirements for use in radiology settings.