PRORAD 2FC

Primary DI
08908021109011
Brand
PRORAD 2FC
Company
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
Model
A60-2FC-0001
Device 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.
Published
2026-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
KPRSystem, X-Ray, Stationary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183541000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183541000ProRad 2FC and ProRad 3NC Stationary Radiographic SystemsPrognosys Medical Systems Private Limited2019-01-24KPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908021109011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908021109011089080211090118908021109011

GMDN Terms#

Term, Definition table
TermDefinition
Stationary basic diagnostic x-ray system, digitalAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Regulatory Flags#

DUNS number
872343077
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08908021109004PRORAD 3NCA90-3NC-00012026-05-07
08908021109097PRORAD ATLAS ULTRAPORTABLEA86-ATL-00012026-05-07
08908021109103PRORAD ATLAS ULTRAPORTABLE PLUSA87-ATL-00012026-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908021109004PRORAD 3NCPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDKPR2026-05-07
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