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Cronex Radiation Therapy Verification Cassette

by E.I. Dupont DE Nemours & Co., Inc.

510(k) K953725

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 NumberK953725 Date6 Sep 1995ClearedStatusActive

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  • Withdrawn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
IXA
Device Class
Class II
Regulation
21 CFR Part 892.1850
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Cronex Radiation Therapy Verification Cassette is a radiographic film cassette used in medical imaging applications. It is designed to facilitate the capture of radiation therapy verification images within a clinical radiology setting.

This device is classified as an FDA class 2 medical device under regulation number 892.1850. It has received FDA 510(k) clearance as a substantially equivalent product.

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Questions

AI-generated answers, 25 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 is the primary purpose of the Cronex Radiation Therapy Verification Cassette?

    This device is a radiographic film cassette specifically designed to facilitate the capture of radiation therapy verification images within a clinical radiology setting.

  • What is the regulatory classification of this device?

    The Cronex Radiation Therapy Verification Cassette is classified as an FDA Class 2 medical device under regulation number 892.1850. It has received FDA 510(k) clearance as a substantially equivalent product.

  • Who is the manufacturer of this radiographic cassette?

    The device is manufactured by E.I. Dupont DE Nemours & Co., Inc., based in Newark, Delaware.