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510(k) Data Aggregation

    K Number
    K231761
    Device Name
    PodSKAN HF Diagnostic X-ray System
    Date Cleared
    2023-10-27

    (133 days)

    Product Code
    Regulation Number
    892.1680
    Why 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
    K220518
    Device Name
    SKANRAD 400
    Date Cleared
    2022-04-01

    (37 days)

    Product Code
    Regulation Number
    892.1680
    Why 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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    K Number
    K212940
    Device Name
    Skanmobile, Skanmobile-Dr
    Date Cleared
    2022-03-04

    (170 days)

    Product Code
    Regulation Number
    892.1720
    Why 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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    K Number
    K172147
    Device Name
    STAR 65
    Date Cleared
    2018-05-25

    (312 days)

    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Skanray Technologies Pvt Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Star 65 multi-parameter Patient Monitoring system is intended to monitor a single Adult. Pediatric or Neonatal patient's vital signs at the bedside or during intra-hospital transport with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead), SpO2, and Respiration, Temperature, Invasive Blood Pressure (Systolic, Diastolic and Mean), Non-invasive Blood Pressure (Systolic and Mean), Capnography (CO2), Cardiac Output (CO) & AGM module. It can display the numeric values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic, Diastolic and Mean), Temperature, CO, EtCO2 and FiCO2, N2O, O2, EtAA and FiAA readings. The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use. It shall be used only by trained clinicians. In addition Star 65 got Arrhythmia and ST detection from 3L/5L ECG measurements. The Arrhythmia and ST analysis module is intended for use with Adult & Pediatric patients and is not intended for use with Neonatal patients(ST and Arrhythmia detection functionality is not available for U.S.A).
    Device Description
    Star 65 is a multi-parameter modular patient monitoring system for continuous monitoring of the physiological parameters like ECG (3/5 lead), Respiration, NIBP, Temperature, SpO2, CO2, Cardiac Output (CO). & Anesthesia Gas Monitoring (AGM) Module (Optional). The modular parameters are IBP, CO and CO2. Star 65 is a 8 channel monitor with 12.1" LED display with touch screen capable of displaying and monitoring ECG, Respiration, SpO2, CO2, IBP, and O2 digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic & Mean), Invasive Blood Pressure (Systolic, Diastolic & Mean), Temperature, EtCO2, FiCO2, IPI, CO, N2O, O2, EtAA, and FiAA readings. Star 65 has 240 Hours tabular and graphical vital trend. Star 65 has a NIBP trend of last 240 readings. Star 65 has Alarm Recall facility with last 48 'Patient Alarms' details. Star 65 has communication features like USB for Thumb drive, Printer, Bar code scanner interface, Ethernet for CNS & Bed to Bed connectivity, HDMI output for External monitor connectivity, External Port for AGM 55 interface, Wi-Fi for CNS, Bed to Bed & Network Printer connectivity. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals, high priority alarms are indicated by red colour, medium priority alarms are indicated by yellow colour & low priority alarms are represented by blue colour. Star 65 has got Drug calculator software package to display drug dosage applied / to be applied for the standard Medicines.
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    K Number
    K170946
    Device Name
    Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant
    Date Cleared
    2017-11-24

    (239 days)

    Product Code
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    Skanray Technologies Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Skan-C, a Mobile Surgical C-Arm X-Ray System, is intended to provide Fluoroscopic and Radiographic images of the patient during Diagnostic, Surgical and Interventional procedures. Examples of Clinical Applications may include Orthopaedic. GI Procedure like Endoscopy and Cholenography. Neurology, Urology Procedures, Vascular, Critical Care and Emergency Room Procedures. Skan-C is not recommended for Cardiac Applications. Skan-C Surgical C-Arm is indication in real time and/or recording of surgical region of interest and anatomy, using X-ray imaging technique.
    Device Description
    SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in quiding medical intervention surgical procedures. The device can also be used for radiographic applications. The device is designed in such a way that it can be moved around and can be positioned for the required anatomical/clinical/procedural position. SKAN-C, a Mobile Surgical C-Arm consists of two units, namely, Mobile Image Intensified C-Arm unit with generator, and a Work-Station for Image display, store and manipulation. C-Arm unit with generator is capable of movements which are essential for patient positioning, like horizontal travel, orbital movement, wig-wag movement and C rotation. The X-ray generator, X-Ray control system and collimator controls are housed in the C-Arm unit.
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    K Number
    K170967
    Device Name
    Intraskan DC Plus
    Date Cleared
    2017-06-08

    (69 days)

    Product Code
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Skanray Technologies Private Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    INTRASKAN DC PLUS is High Frequency extra oral X Ray source to be used for Intra-Oral X-Ray in Dental radiography for diagnostic purpose.
    Device Description
    INTRASKAN DC PLUS is High Frequency extra oral X Ray source to be used for Intra-Oral X-Ray in Dental radiography for diagnostic purpose. The system 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. The Intra Oral X-ray does not have provision to connect to wireless networks or LAN.
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    K Number
    K152831
    Device Name
    Spot Skan
    Date Cleared
    2016-02-23

    (147 days)

    Product Code
    Regulation Number
    870.1130
    Why did this record match?
    Applicant Name (Manufacturer) :

    SKANRAY TECHNOLOGIES PRIVATE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SpotSkan, a multi-parameter Spot Check Device, along with the appropriate accessories mentioned / supplied with the unit, is intended to measure a single adult or pediatric (but not neonatal) patient's vital signs at the physician's clinic. SpotSkan is not a Patient Monitor. Vital signs measured include SpO2, Non-Invasive Blood Pressure, Pulse Rate and Temperature. A thermal recorder is provided for printing measured data. The user is responsible to interpret the measured data made available, and shall be a professional health care provider. The monitor is not intended for home use.
    Device Description
    SpotSkan is SKANRAY's new portable Spot Check Device, which can be used to measure SpO2, Pulse rate, Blood Pressure non-invasively and Tympanic Temperature, for adult and pediatric (but not neonatal) patients. It is a compact device which has only numeric values displayed on a 6.5" LED Backlit TFT LCD display of resolution 640*480, containing SpO2, NIBP, Pulse Rate and Temperature values. It has last 12 patients' readings saved. It does not have continuous monitoring capability of the parameters or any alarms. Interface of a thermal recorder to take print out of real time measurements and values from patient history make the data availability through a hard copy. It has got battery backup of 2 hours, which enables it to continue measurement even during mains power OFF condition. User can enter patient ID, name, age, height, weight; and select mode and sex; these details can be recorded in the thermal print out. The scope of application is in the medical diagnostics, where a general physician will use the monitors in clinics. The user is responsible to interpret the measured data made available, and shall be a professional health care provider. The monitor is not intended for home use.
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    K Number
    K151512
    Device Name
    Star 60
    Date Cleared
    2016-02-14

    (255 days)

    Product Code
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SKANRAY TECHNOLOGIES PRIVATE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Star 60 multi-parameter Patient Monitoring system is intended to monitor a single Adult, Pediatric or Neonatal patient's vital signs at the bedside or during intrahospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3L / 5L), SpO2, Respiration, Temperature, NIBP, IBP, IBP and Capnography (CO2). It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic, Diastolic and Mean), Invasive Blood Pressure (Systolic and Mean), Temperature, EtCO2, FiCO2 readings. The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
    Device Description
    STAR 60 is a patient monitor with a wide range of communication options. Capacitive sensing buttons in keyboard is introduced. It fits in clearly to a new age of patient monitoring. - ECG+RESPIRATION+TEMPERATURE MODULE: This module is divided in area and functionality between the main board and the ECG child card. The Temperature section and the DC-DC section of the ER2T lie in the main board. - SpO2: This module is inbuilt inside the monitor on the main board. It is used to measure the partial pressure of oxygen in the human body. - . NIBP: This module is inbuilt inside the monitor on to the chassis. It is used to non-invasively measure the systolic, diastolic & mean blood pressure. - CO2: This module is inbuilt inside the monitor on to the chassis. It is used to measure the level of CO2 in the blood (EtCO2 & FiCO2). - . IBP: STAR 60 can support IBP modules. For ease of understands we shall name as IBP1 & IBP 2. IBP 1/2 module is inbuilt on the main board. It is used to invasively measure the systolic and diastolic blood pressure.
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    K Number
    K150512
    Device Name
    STAR 90
    Date Cleared
    2015-06-17

    (110 days)

    Product Code
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    SKANRAY TECHNOLOGIES PVT LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The STAR 90 multi-parameter Patient Monitoring system is intended to monitor a single adult, pediatire or neonatal patient's vital signs at the bedside or during intra-hospital transport along with the appropriate accessories mentioned / supplied with the unit. Vital signs parameters include ECG (3 lead / 12 Lead), SpO2, Respiration, Temperature and Capnography (CO2) , IBP. It can also display the digital values of HR/PR, SpO2, RR, Non-Invasive Blood Pressure (Systolic and Mean), Temperature , IBP , EtCO2 and FiCO2 readings. The user, responsible to interpret the monitored data made available, will be a professional health care provider. The device permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals. The monitor is not intended for home use.
    Device Description
    The STAR 90 Multi-Parameter Patient Monitoring System is a Semi Modular Patient monitor with a wide range of communication options, touch screen and capacitive sensing buttons. Modularity in this monitor is achied by providing 3 slots wherein the parameter modules that fit into these modules are hot swappable i.e. they can be connected or disconnected from the unit without switching off the unit. The module is detected at run time. Patient monitoring modules include: - . ECG+RESPIRATION+TEMPERATURE MODULE: This module is divided in area and functionality between the interface card and the ECG child card. The Temperature section and the DC-DC section of the ER2T lie in the interface card. - SpO2: This module is inbuilt inside the monitor on the interface card, but there is ● an option to jack an external SpO2 module in one of the jackable slots. It is used to measure the partial pressure of oxygen in the human body. - NIBP: This module is inbuilt inside the monitor on the interface card. It is used to non-invasively measure the systolic and diastolic blood pressure. - CO2: This module can be jacked into one of the jackable slots. It is used to measure the level of CO2 in the blood (EtCO2 & FiCO2). When AGM is used this module will not be available - . IBP: STAR 90 can support 2 IBP modules. For ease of understanding we shall name the 1st IBP as IBP ½ and the 2nd IBP as IBP ¾. IBP ½ module is inbuilt in the interface card, whereas the IBP ¾ can be jacked in one of the slots. It is used to invasively measure the systolic and diastolic blood pressure - . AGM: The connectivity for this module is inbuilt inside the interface card of the system, but the AGM module has to be connected through the connector provided. It is used to measure anesthesia gas concentration, CO2 and O2.This is optional module in place of CO2 module.
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    K Number
    K111330
    Device Name
    AIR TECHNIQUES HIGH FREQUENCY INTRA-ORAL X-RAY
    Date Cleared
    2011-05-27

    (16 days)

    Product Code
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    SKANRAY TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Air Techniques High Frequency Intra-Oral X-Ray is to be used as an extraoral source of X-Rays in Dental radiography.
    Device Description
    Air Techniques High Frequency Intra-Oral X-Ray is an X-Ray System with an extraoral X-Ray source for dental diagnostic radiography. The system 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. Air Techniques High Frequency Intra-Oral X-Ray consists of the following main components: Base Unit, Tube Housing, Beam Limiting Device-inbuilt with tube Housing, Control Console, 9.84 Ft (3 m) coiled cord, Rotating yoke for tube housing mounting, Extension arm, Scissor arm. Optional Components: Long Cone 11.8in (300mm), 9.84 Ft (3m) coiled cord with exposure switch. The Power supply is regulated to provide a selectable 50 to 70 kVp in step of 1kV at a selectable tube current of 4, 6, 7, or 8 mA. The range of exposure times is 0.04 to 4.00 seconds with 1:15 duty. Predefined exposure parameters kV, mA & exposure time values may be stored in, selected & operated via the operator control panel.
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