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FEEL-DRCS

by Imfou Co., Ltd.

510(k) K110033

Active European Union and United States

CE MDD 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) K110033↗

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 · Traditional NumberK110033 Date15 Sep 2011ClearedStatusActive
European UnionCE/MDD 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  • Withdrawn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/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
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 FEEL-DRCS is a Digital Radiography Cassette System designed for capturing and processing radiographic images in radiology settings. It integrates with digital radiography systems to replace traditional film-based imaging, enabling high-resolution, real-time image acquisition for diagnostic purposes.

This system is supplied as a reusable device intended for use in radiology departments, adhering to FDA 510K clearance and MDD compliance. It requires proper handling, storage, and maintenance in accordance with manufacturer guidelines to ensure optimal performance and image quality. No specific sterility or MRI safety information is provided in the data.

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.

  • What types of radiology settings is the FEEL-DRCS intended for, and how does it differ from traditional film-based systems?

    The FEEL-DRCS is designed for use in radiology departments where high-resolution, real-time radiographic imaging is required. Unlike traditional film-based systems, it integrates with digital radiography systems to capture and process images electronically, eliminating the need for physical film. This allows for immediate image review, storage, and transmission, improving workflow efficiency and diagnostic accuracy.

  • Is the FEEL-DRCS a single-use or reusable device, and what maintenance does it require?

    The FEEL-DRCS is a reusable device, meaning it is built to be used repeatedly in radiology settings. To maintain optimal performance and image quality, it requires proper handling, storage, and regular maintenance as outlined by the manufacturer. This includes cleaning, calibration, and adherence to operational guidelines to ensure consistent functionality.

  • What regulatory pathways has the FEEL-DRCS followed, and how does this affect its use in clinical settings?

    The FEEL-DRCS has undergone FDA 510(k) clearance and complies with the Medical Device Directive (MDD). These pathways confirm that the device meets regulatory standards for safety and effectiveness in digital radiography applications. Clinicians and facilities can rely on this regulatory history to ensure the device adheres to established guidelines for use in radiology departments.

  • Does the FEEL-DRCS come with any specific storage or handling instructions to preserve its performance?

    While the provided data does not specify detailed storage or handling instructions, the manufacturer recommends following guidelines to ensure optimal performance. Since it is a reusable device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper maintenance, as instructed by Imfou Co., Ltd., is essential to preserve functionality and image quality over time.