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ACIES

by Konica Minolta Medical & Graphic, Inc.

510(k) K101842

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK101842 Date4 Feb 2011ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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, 1 Oct 2026

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

The ACIES is a Class II X-ray imaging system designed for radiology applications. It provides digital radiographic imaging to capture high-quality images of internal body structures for diagnostic purposes. This device is intended for use in medical facilities where radiographic examinations are conducted, supporting clinical decision-making through precise imaging.

The ACIES is supplied as a reusable medical device and is intended for use in radiology departments within healthcare settings. It is not described as sterile or single-use, and no specific MRI safety classification is provided. The system is authorized under FDA 510(k) clearance (K101842) and falls under the product code LLZ, classified under the Radiology advisory committee. Storage and handling instructions are not detailed in the provided data.

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Questions

AI-generated answers, 1 Oct 2026

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

  • What is the ACIES digital X-ray imaging system used for?

    The ACIES is designed for capturing high-quality digital radiographic images of internal body structures. These images support diagnostic evaluations and clinical decision-making in radiology settings, helping healthcare providers assess conditions such as fractures, infections, or abnormalities in bones and organs.

  • Is the ACIES system single-use or reusable?

    The ACIES is supplied as a reusable medical device. Unlike single-use devices, it is intended for repeated use within radiology departments after proper cleaning, maintenance, and sterilization procedures—though specific sterilization instructions are not detailed in the provided data.

  • What regulatory approval does the ACIES hold?

    The ACIES received FDA 510(k) clearance under the reference number K101842. This clearance indicates the device was determined to be substantially equivalent to a legally marketed predicate device, meeting regulatory requirements for safety and effectiveness in radiographic imaging applications.

  • Is the ACIES system sterile upon delivery?

    The ACIES is not described as a sterile device upon delivery. Since it is reusable, it must undergo appropriate cleaning and reprocessing between uses to maintain safety and performance standards in clinical environments.

  • What types of medical facilities can use the ACIES?

    The ACIES is intended for use in radiology departments within healthcare facilities, including hospitals, clinics, and diagnostic centers where radiographic examinations are conducted. Its design supports routine diagnostic imaging for a variety of patient assessments.