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Decimal Tissue Compensator/Intensity Modulator

by Southeastern Radiation Products, Inc.

510(k) K040804

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 NumberK040804 Date28 Apr 2004ClearedStatusActive

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  • Withdrawn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
IXI
Device Class
Class II
Regulation
21 CFR Part 892.5710
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 Decimal Tissue Compensator/Intensity Modulator is a block, beam-shaping device used in radiation therapy. It compensates for tissue irregularities and modulates radiation intensity to ensure uniform dose distribution during external beam treatments, improving treatment precision for patients with complex anatomical structures.

This device is supplied as a custom-manufactured solid filter for individual patient cases, designed based on treatment planning software outputs. It is intended for single-use in radiation oncology settings and is classified as a Class II medical device under FDA regulations. The product is fabricated from materials suitable for radiation therapy applications and requires proper handling and storage to maintain sterility and integrity before use.

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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 Decimal Tissue Compensator/Intensity Modulator used for?

    This device is a block, beam-shaping tool designed to compensate for tissue irregularities and adjust radiation intensity during external beam treatments. By ensuring uniform dose distribution, it improves precision for patients with complex anatomical structures, such as those requiring tailored radiation therapy plans.

  • How is the Decimal Tissue Compensator/Intensity Modulator supplied?

    The device is supplied as a custom-manufactured solid filter tailored to individual patient cases. It is created based on outputs from treatment planning software, ensuring the compensator aligns with the specific radiation therapy requirements for each patient.

  • Is the Decimal Tissue Compensator/Intensity Modulator intended for single-use or reuse?

    This device is classified for single-use in radiation oncology settings. Its design and materials are optimized for one-time application to maintain sterility and integrity, preventing contamination or degradation between uses.

  • What materials is the Decimal Tissue Compensator/Intensity Modulator fabricated from?

    The device is made from materials suitable for radiation therapy applications, ensuring compatibility with the treatment environment and patient safety. Specific material details are provided by the manufacturer to meet regulatory standards for medical devices.

  • How should the Decimal Tissue Compensator/Intensity Modulator be stored before use?

    Proper storage is critical to preserve sterility and structural integrity. The device should be stored in a clean, dry environment, away from direct sunlight or extreme temperatures, following manufacturer guidelines to prevent damage or contamination before use.