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510(k) Data Aggregation
K Number
K231761Device Name
PodSKAN HF Diagnostic X-ray System
Manufacturer
Date Cleared
2023-10-27
(133 days)
Product Code
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
Skanray Technologies Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
PodSKAN HF Diagnostic X-Ray System is intended for use by the qualified and trained clinicians or radiographers for generating X-rays of feet. It can be used for adults and paediatrics.
PodSKAN is not intended for Mammography and Fluoroscopy Applications.
Device Description
PodSKAN is an advanced high frequency type X-Ray system designed for superior image quality with powerful 2.8KW generator and very low leakage radiation. The system houses two microprocessors, one for control/supervisory functions and another one man-machine/User interface. It can be easily plugged into 16A wall socket with 120 VAC or 240 VAC, 50/60 Hz. The technology incorporates feedback circuits to ensure highest accuracy & reproduceability of X-Ray output. It consists of
- . Tube head assembly (including collimator and goniometer)
- Base foot platform and side handle for patient support .
- External console and Hand switch .
PodSKAN HF diagnostic X-ray system can be used with Film, Computed Radiography (CR) and Digital Radiography system image receptors along with associated image capture software. Skanray recommends using 510(k) cleared flat panel detectors with AED functionality wired or wireless of size 10"x12" or 14"x17"and image acquisition systems to maintain compliance and quality
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K Number
K212940Device Name
Skanmobile, Skanmobile-Dr
Manufacturer
Date Cleared
2022-03-04
(170 days)
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
Skanray Technologies Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SKANMOBILE and SKANMOBILE-DR are intended for use in generating radio graphic images of human anatomy in all general-purpose x-ray diagnostic procedures for all patient population including paediatrics and adults. It may be used in radiology departments, emergency rooms, intensive care units, operating rooms, orthopaedics clinics, military camps, paediatric clinics, medical camps and small hospitals.
SKANMOBILE and SKANMOBILE-DR are indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen, extremities and other body parts with the patient sitting, standing or lying in the prone or supine position. The device has been designed for indoor usage and used/operated only by the trained & qualified physicians or x-ray technologist.
SKANMOBILE and SKANMOBILE-DR are not intended for mammographic applications.
Device Description
The SKANMOBILE and SKANMOBILE-DR are X-ray systems which generates high frequency X-rays for diagnostic radiography in all patient population including pediatrics and adults.
SKANMOBILE houses two microprocessors: one for control/supervisory functions and another for man-machine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output.
SKANMOBILE consists of following sub-assemblies:
1. Tube head
2. SKANMOBILE trolley
SKANMOBILE-DR is a variant based on SKANMOBILE platform. SKANMOBILE-DR is a digital radiographic system designed for optimized image quality featuring wireless flat panel detector and operator console for digital imaging integrated with high frequency generator. SKANMOBILE-DR is similar to SKANMOBILE where tube head generator, collimator, and counter balancing mechanism remains same. The new or modified assemblies/sub-assemblies that are used in SKANMOBILE-DR are as follows:
1. Touchscreen operator console.
2. Modified brake mechanism for wheels
3. Modified cassette tray to house the cassette / flat panel detectors.
Both SKANMOBILE and SKANMOBILE-DR consists of software/firmware which enables the operation of the devices.
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