Device
The PRORAD ATLAS ULTRAPORTABLE Digital X-ray Unit is a state-of-the-art ultraportable Digital x-ray solution that comprises of high frequency generator for precise x-ray delivery,...
Manufacturer
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
Model: A86-ATL-0001
DI: 08908021109097
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Distribution End: 2092-03-15
Description
The PRORAD ATLAS ULTRAPORTABLE Digital X-ray Unit is a state-of-the-art ultraportable Digital x-ray solution that comprises of high frequency generator for precise x-ray delivery, FPD and ergonomically and aesthetically designed portable unit.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0cb01980-a3e0-4b16-81d1-8432caa26e4b
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:
08908021109097
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 37606
Name: Diagnostic x-ray system generator, portable
Definition:
An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a portable x-ray system, e.g., a system intended to be easily disassembled and reassembled at various locations. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). This GMDN code includes transformer and inverter generator designs. Portable x-ray generators typically comprise a control assembly (console) and high voltage transformer assembly or are of a mono-tank generator design.
FDA Product Codes
IZL
System, X-Ray, Mobile
Premarket Submissions
Submission Number:
K243473
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:
Percent (%) Relative Humidity
Item #2 - Storage Handling Low - @attributes - Value:
30
Item #2 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #2 - Storage Handling High - @attributes - Value:
75
Item #2 - Storage Handling Type:
Handling Environment Humidity
Item #3 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling Low - @attributes - Value:
70
Item #3 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #3 - Storage Handling High - @attributes - Value:
106
Item #3 - Storage Handling Type:
Handling Environment Atmospheric Pressure
Item #4 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #4 - Storage Handling Low - @attributes - Value:
-20
Item #4 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #4 - Storage Handling High - @attributes - Value:
60
Item #4 - Storage Handling Type:
Storage Environment Temperature
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