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Enhanced Compensating Filter

by Computerized Medical Systems, Inc.

510(k) K000137

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 NumberK000137 Date17 Apr 2000ClearedStatusActive

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  • Withdrawn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 Enhanced Compensating Filter is a beam-shaping device used in radiation therapy. It is classified as a Class II medical device under the product code IXI and regulation number 892.5710.

The device received FDA 510(k) clearance (K000137) on April 17, 2000, following a traditional review process. It was determined to be substantially equivalent to a legally marketed device and is manufactured by Computerized Medical Systems, Inc. in St. Louis, Missouri.

Other devices from Computerized Medical Systems, Inc.

See all devices from Computerized Medical Systems, Inc. →

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 Enhanced Compensating Filter used for?

    The Enhanced Compensating Filter is a beam-shaping device used in radiation therapy to modify the shape and intensity of radiation beams, allowing for more precise targeting of tumors while sparing surrounding healthy tissue.

  • How is the Enhanced Compensating Filter supplied and is it reusable?

    The device is supplied as a physical beam-shaping filter intended for use with radiation therapy equipment. Based on its classification and typical use in external beam radiation therapy, it is designed for reuse after proper cleaning and quality assurance checks between patients, as it does not come into direct contact with the patient.

  • What regulatory pathway was used for the Enhanced Compensating Filter?

    The Enhanced Compensating Filter received FDA 510(k) clearance (K000137) on April 17, 2000, through a traditional review process, demonstrating substantial equivalence to a legally marketed predicate device.