Device
The PRORAD 3NC Ceiling suspended system is very versatile and robust with light weight design. The ceiling suspension consists of ceiling rail system with longitudinal travel (300...
Manufacturer
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
Model: A90-3NC-0001
DI: 08908021109004
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Distribution End: 2092-05-07
Description
The PRORAD 3NC Ceiling suspended system is very versatile and robust with light weight design. The ceiling suspension consists of ceiling rail system with longitudinal travel (300 cm) and transversal travel (200 cm). The telescopic column travels a vertical distance (160 cm). The longitudinal, transverse and vertical travel is automatic.
All the braking mechanism of the ceiling suspension is Electromagnetic. The ceiling suspension has wide range of rotation around the horizontal and vertical axis. The system is powered by a three phase X-Ray generator designed to carry out high precision radiological exposures that can be used in an easy way with high reliability. It is fully integrated with Flat panel detector System and components such as the Vertical Bucky and X-Ray tubes such that the productivity of the department is at its best.
The ceiling suspended system further offers configurations based on the Hospital and radiologists’ need –Manual/Auto tracking / Full Auto; Single / Dual detector; Wired / Wireless Detector; precisely every “choice and convenience” a Radiologist and Technologist can demand from an imaging equipment. The four-way floating tabletop movement and adjustable table height is ideally suited for a dual detector system and makes it comfortable for a Radiographer to work on a physically limited patient.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7830c41f-db75-42e1-b4f2-bef278a64c72
Distribution Status:
In Commercial Distribution
DUNS Number:
872343077
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08908021109004
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 37645
Name: Stationary basic diagnostic x-ray system, digital
Definition:
An assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.
FDA Product Codes
KPR
System, X-Ray, Stationary
Premarket Submissions
Submission Number:
K183541
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
10
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
40
Item #1 - Storage Handling Type:
Handling Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
-20
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
60
Item #2 - Storage Handling Type:
Storage Environment Temperature
Item #3 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling Low - @attributes - Value:
30
Item #3 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling High - @attributes - Value:
75
Item #3 - Storage Handling Type:
Handling Environment Humidity
Item #4 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #4 - Storage Handling Low - @attributes - Value:
70
Item #4 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #4 - Storage Handling High - @attributes - Value:
106
Item #4 - Storage Handling Type:
Handling Environment Atmospheric Pressure
Item #5 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #5 - Storage Handling Low - @attributes - Value:
50
Item #5 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #5 - Storage Handling High - @attributes - Value:
106
Item #5 - Storage Handling Type:
Storage Environment Atmospheric Pressure