Device
The PRORAD 2FC system is a Digital radiographic X-ray intended to be used to Perform X-ray Examinations for diagnostic procedures.
Manufacturer
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
Model: A60-2FC-0001
DI: 08908021109011
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 2FC system is a Digital radiographic X-ray intended to be used to Perform X-ray Examinations for diagnostic procedures.
The PRORAD 2FC system holds the X-ray tube in Tube Column. Tube Column consists Longitudinal Floor rail system with longitudinal travel (1100mm) and telescopic Tube with transversal travel (Minimum of 100 mm). The Tube holder system is fixed to vertical carriage which travels in vertical distance (Minimum of 1420 mm). The Tube holder system also rotates the tube about transversal axis for a range of ± 135 Degree. The vertical travel is both automatic and Manual, Longitudinal, Tube rotation and Telescopic travel are manual only. All the braking mechanism of the Tube Carrier system is Electromagnetic.
The PRORAD 2FC system holds the Detector in Bucky column. Bucky column also have similar set of movements except that Bucky column does not have transversal movement. Bucky holder travels (1100 mm) in longitudinal axis on longitudinal rails. Vertical axis travel 1330 mm of Bucky holder system is both manual and automatic. Longitudinal and Bucky rotation movements are only manual.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2b78e7e7-94c9-4a75-822e-71572c685fe0
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:
08908021109011
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