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PLURIX C - Radiographic Table

by Tecnomed, Inc. 510(k)

Active United States

510(k) K781066

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781066 Date17 Jul 1978ClearedStatusActive

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  • Withdrawn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 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IXQ
Models / Variants
Radiographic Table
Device Class
Class II
Regulation
21 CFR Part 892.1980
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Plurix C Radiographic Table is a stationary-top radiographic table designed for use in radiology procedures. It is classified as a radiographic table under the FDA’s nomenclature, specifically a stationary-top model, and is intended for imaging patients in various radiographic and fluoroscopic applications.

This device is supplied as a reusable medical instrument and is regulated under FDA’s Class II special controls (product code IXQ). It was granted FDA 510(k) clearance (K781066) in 1978, with no indication of MRI compatibility or sterility requirements in the available data. The table is intended for use in radiology departments and adheres to regulatory standards outlined in 21 CFR 892.1980.

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Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • Is the Plurix C Radiographic Table designed for single-use or can it be reused in clinical settings?

    The Plurix C Radiographic Table is explicitly supplied as a reusable medical instrument. Since it is classified under FDA’s Class II special controls and lacks any mention of single-use or sterility requirements in the available data, it is intended for repeated use in radiology departments after proper cleaning and maintenance.

  • What types of imaging procedures is the Plurix C Radiographic Table intended to support?

    The Plurix C Radiographic Table is designed for radiographic and fluoroscopic imaging applications, allowing patients to be positioned for various X-ray and fluoroscopy procedures in radiology departments. Its stationary-top design ensures stability for these common diagnostic imaging needs.

  • How is the Plurix C Radiographic Table regulated by the FDA, and what does that mean for its use?

    The Plurix C Radiographic Table is regulated under FDA’s Class II special controls (product code IXQ) and was granted 510(k) clearance (K781066) in 1978. This means it has been deemed substantially equivalent to a predicate device and must comply with FDA’s radiographic table standards (21 CFR 892.1980), ensuring safety and performance for use in radiology settings.

  • Are there different sizes or models of the Plurix C Radiographic Table, and if so, how are they identified?

    The available data lists multiple registration numbers (e.g., 3003768277, 3015232217) and FEI numbers (e.g., 3002619595, 1721113) associated with the Plurix C Radiographic Table, suggesting there may be various models or configurations registered under this name. However, specific size or model distinctions (e.g., table width, weight capacity, or top design) are not detailed in the provided data.

  • Does the Plurix C Radiographic Table have any special storage or maintenance requirements?

    While the data does not explicitly outline storage or maintenance protocols, as a reusable radiographic table, it should be stored in a clean, dry environment to prevent damage or contamination. Proper cleaning and periodic inspections are recommended to ensure compliance with FDA’s radiographic table standards (21 CFR 892.1980) and maintain functionality for repeated use in radiology.