PRORAD ATLAS ULTRAPORTABLE PLUS

Primary DI
08908021109103
Brand
PRORAD ATLAS ULTRAPORTABLE PLUS
Company
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
Model
A87-ATL-0001
Device description
The PRORAD ATLAS ULTRAPORTABLE PLUS Digital X-ray system is intended to deliver high-quality, diagnosticradiographic images of the body extremities. It utilizes a portable X-ray Unit, flat-panel detector and real-time imageprocessing using software to produce clear digital images, enabling fast and accurate diagnosis. The portable X-ray unit isintended to be used only when stand/tripod mounted.The PRORAD ATLAS ULTRAPORTABLE PLUS X-ray digital system is predominantly employed in various settings,including health-care centres, temporary and emergency health centres (established, especially in pandemiccircumstances), outreach and field interventions (such as mobile clinics/vans, screening campaigns, and home care), andtele-radiology solutions in remote areas.The primary users anticipated for the system include radiographers, radiological technologists, and medical professionalswho are trained in safety, radiation protection, and image management.
Published
2026-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZLSystem, X-Ray, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243473000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243473000PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUSPrognosys Medical Systems Private Limited2025-07-29IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908021109103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908021109103089080211091038908021109103

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray system generator, portableAn 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.

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

Contacts#

Phone, Email table
PhoneEmail
8049325700support@prognosysmedical.com

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
08908021109011PRORAD 2FCA60-2FC-00012026-05-07
08908021109097PRORAD ATLAS ULTRAPORTABLEA86-ATL-00012026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08908021109097PRORAD ATLAS ULTRAPORTABLEPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-05-07
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