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DICOM Theater

by Ferguson Medical 510(k)

Active United States

510(k) K033153

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK033153 Date23 Apr 2004ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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 DICOM Theater is a digital imaging and communications in medicine (DICOM) viewing system designed for radiology applications. It facilitates the display and review of digital medical images by trained medical practitioners, enabling collaborative analysis and diagnostic evaluation in a clinical setting. This system integrates with existing radiology workflows to enhance image interpretation and communication among healthcare providers.

Supplied as a reusable medical device, the DICOM Theater is intended for use in radiology departments and imaging centers. It is cleared under FDA 510(k) with the product code LLZ and K-number K033153, following a Substantially Equivalent (SESE) determination by the Radiology (RA) Advisory Committee. No specific sterility or MRI safety information is provided in the available data, and its operational specifications are governed by regulatory compliance with the FDA’s Class II requirements.

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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 DICOM Theater used for in a clinical setting?

    The DICOM Theater is designed for radiology applications to display and review digital medical images. It integrates with existing workflows to improve image interpretation and facilitate communication among healthcare providers, supporting collaborative diagnostic evaluations.

  • Is the DICOM Theater a single-use or reusable device?

    The DICOM Theater is supplied as a reusable medical device. This means it is intended for repeated use in radiology departments and imaging centers, provided it is properly maintained and cleaned according to manufacturer guidelines.

  • Does the DICOM Theater require sterilization before use?

    No specific sterility information is provided for the DICOM Theater in the available data. Since it is a reusable device, it should be cleaned and maintained according to standard medical device reprocessing protocols to ensure safety and functionality.

  • What regulatory pathway was followed for FDA clearance of the DICOM Theater?

    The DICOM Theater was cleared under the FDA’s 510(k) process with a Substantially Equivalent (SESE) determination by the Radiology (RA) Advisory Committee. It falls under product code LLZ and has K-number K033153, adhering to Class II regulatory requirements.

  • Can the DICOM Theater be used in environments with MRI equipment?

    No specific MRI safety information is provided for the DICOM Theater in the available data. If used near MRI equipment, ensure compliance with all applicable safety standards and guidelines to avoid interference or hazards.