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CAMTEX 1000

by Digital Imaging Co. of America

510(k) K840134

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 NumberK840134 Date16 Mar 1984ClearedStatusActive

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  • Withdrawn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
JAA
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 CAMTEX 1000 is an X-ray fluoroscopic system with image intensification, designed for radiology procedures. It is a Class II medical device that captures and enhances X-ray images for diagnostic imaging purposes.

The CAMTEX 1000 is manufactured by Digital Imaging Co. of America and was cleared by the FDA in 1984 under 510(k) number K840134. It is supplied as a system with various image intensifier models and is regulated under product code JAA. The device is intended for use in radiology settings and requires appropriate storage conditions.

Questions

AI-generated answers, 21 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 CAMTEX 1000 used for?

    The CAMTEX 1000 is an X-ray fluoroscopic system with image intensification designed for radiology procedures. It captures and enhances X-ray images for diagnostic imaging purposes in medical settings.

  • How is the CAMTEX 1000 supplied?

    The CAMTEX 1000 is supplied as a complete system with various image intensifier models. It is manufactured by Digital Imaging Co. of America and requires appropriate storage conditions to maintain functionality.

  • What is the regulatory status of the CAMTEX 1000?

    The CAMTEX 1000 is a Class II medical device that was cleared by the FDA in 1984 under 510(k) number K840134. It is regulated under product code JAA and was determined to be substantially equivalent to other devices on the market.

  • What are the specifications of the CAMTEX 1000?

    The CAMTEX 1000 features various image intensifier models with different FEI numbers. It is a fluoroscopic system designed for diagnostic imaging, with specific technical details available through the manufacturer's documentation.