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510(k) Data Aggregation
K Number
K220518Device Name
SKANRAD 400
Manufacturer
Date Cleared
2022-04-01
(37 days)
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Skanray Technologies Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SKANRAD 400 is intended for use in generating X-Rays & radiographic images of human anatomy including skull, spinal column, chest, abdomen, extremties and other body parts in all general-purpose X-ray diagnostic procedures. The device is intended for use in paediatric and adult. It may be used in radiology departments, paediatrics, orthopaedics and clinics. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. Device is designed to be used with conventional film/screen or computed radiography (CR) cassettes / DR system. The system has been designed for indoor usage. It is intended for qualified medical persomel or operators who have been trained in the use of X-Ray equipment. SKANRAD 400 is not intended for mammography.
Device Description
SKANRAD 400 is a high frequency radiography system with 32kW generator X-Ray power. It can be used with table (recumbent position) as well as chest stand (standing position) for general radiography purpose. Electronic circuits incorporated for control, user interface, feedback circuits to ensure accuracy & reproducibility of X-Ray output. lt consists of:
1. Tube head and collimator assembly
2. Floating table assembly
3. Chest stand assembly
4. HV generator assembly
SKANRAD 400 can be used with Film, Computed Radiography (CR) and Digital Radiography system image receptors along with associated image capture software.
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