Plurix C Radiographic Table
by Tecnomed, Inc. 510(k)
Active
510(k) K781066
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781066 | Date17 Jul 1978 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- IXQ
- Models / Variants
- 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
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.
Other devices from Tecnomed, Inc.
Questions
AI-generated answers, 19 Sep 2026
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.