PRORAD 3NC

Primary DI
08908021109004
Brand
PRORAD 3NC
Company
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
Model
A90-3NC-0001
Device 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.
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
08908021109004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908021109004089080211090048908021109004

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
08908021109011PRORAD 2FCA60-2FC-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
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