ProRad 2FC and ProRad 3NC Stationary Radiographic Systems
by Prognosys Medical Systems Private Limited
510(k) K183541
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK183541 | Date24 Jan 2019 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KPR
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The ProRad 2FC and ProRad 3NC Stationary Radiographic Systems are diagnostic imaging devices intended for use by qualified, trained doctors or technicians on both adult and pediatric subjects. These systems are designed to take diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts, with applications that can be performed with the patient sitting, standing, or lying in the prone or supine position.
The ProRad 2FC is a digital radiography system that enables users to carry out all general radiographic procedures, while the ProRad 3NC is a ceiling suspended radiography system that incorporates an aluminum ceiling rail system with a carriage for an Over Head Tube column. These systems are supplied by Prognosys Medical Systems Private Limited and have received FDA 510(k) clearance with the product code KPR. They are intended for stationary use in radiology settings and are not specified as single-use or reusable in the provided data.
Other devices from Prognosys Medical Systems Private Limited
Questions
AI-generated answers, 22 Sep 2026
What are the ProRad 2FC and ProRad 3NC systems used for?
These are diagnostic imaging devices designed for qualified medical professionals to take radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. The ProRad 2FC is a digital system for general procedures, while the ProRad 3NC is ceiling-suspended with an overhead tube column.
How are the ProRad systems supplied and what is their regulatory status?
The systems are supplied by Prognosys Medical Systems Private Limited. They have received FDA 510(k) clearance with product code KPR, making them substantially equivalent to predicate devices for stationary use in radiology settings.
Can the ProRad systems be used on both adult and pediatric patients?
Yes, these systems are intended for use on both adult and pediatric subjects. They can be operated with patients in sitting, standing, prone, or supine positions, allowing for versatile diagnostic imaging across different patient needs.
Are the ProRad systems single-use or reusable?
The provided data does not specify whether the ProRad 2FC and ProRad 3NC systems are single-use or reusable. They are described as stationary radiographic systems intended for use in radiology settings, but no information regarding their reusability is included in the specifications.