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Found 25 results
510(k) Data Aggregation
K Number
K250010Device Name
EXTRON 3; EXTRON 5; EXTRON 7
Manufacturer
DRTECH Corporation
Date Cleared
2025-06-10
(159 days)
Product Code
OWB, JAA, OXO
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
DRTECH Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EXTRON Series are a mobile fluoroscopic X-ray system with high output capacity, high thermal capacity and high resolution image processing system, which provides X-ray images of the patient's anatomy during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis.
Examples of a clinical application may include: Neurosurgery, Orthopedics, Anesthesiology, Urology, Gynecology, Internal Medicine
(※ This device is not intended for mammography applications.)
Device Description
EXTRON Series are mobile fluoroscopic X-ray systems with high output capacity, high thermal capacity, and high-resolution image processing systems that provide X-ray images of the patient's anatomical structures during surgery or treatment. This device plays an important role in emergency injury treatment, orthopedic surgery, neurosurgery surgery, bone surgery, etc. This device has a function to save important a specific images as records, so you can easily search for the images and transmit it to the PACS system in the hospital to help the medical staff in diagnosis.
The EXTRON Series are composed of a C-arm main body and a monitor cart. The C-arm main body is composed of an X-ray tube, a flat panel detector, a collimator, a generator, a touch panel, foot switch, hand switch and an XConsoleOP program, while the monitor cart is composed of a monitor, a thermal transfer printer, a mouse, a keyboard and an XConsole program.
The operating principle of the device is designed to expose the patient to X-ray beams. The range of X-ray irradiation are adjusted by the collimator.
X-rays can penetrate into the human body through a two-step conversion process.
X-ray photons are converted into light. The light is then converted into electrical signals through the sensor. The electrical charges are transmitted as the sensor output and converted into signals. These signals are digitized and captured by memory. The captured images are processed and displayed on the monitor. The displayed images can be saved or transmitted to an external storage device, such as a network printer.
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K Number
K242770Device Name
EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG
Manufacturer
DRTECH Corporation
Date Cleared
2025-03-20
(188 days)
Product Code
MQB, MOB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
DRTECH Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EXPD 114, EXPD 114P, EXPD 114G, EXPD 114PG Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications. It is intended for both adult and pediatric populations.
Device Description
EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG are flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-ray film or an image plate as an image capture medium. EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form.
EXPD 114, EXPD 114G, EXPD 114P, EXPD 114PG are indirect conversion devices in the form of a square plate in which converts the incoming X-rays into visible light. This visible light is then collected by an optical sensor, which generates an electric charges representation of the spatial distribution of the incoming X-ray quanta.
The charges are converted to a modulated electrical signal thin film transistors. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing.
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K Number
K243443Device Name
EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP
Manufacturer
DRTECH Corporation
Date Cleared
2025-03-19
(133 days)
Product Code
MQB, MOB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
DRTECH Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digital X-ray detector, EXPD-N Series, is designed for use in digital imaging solutions for general radiographic diagnosis of human anatomy. This device is intended for use in all general diagnostic procedures, replacing film or screen-based radiographic systems for both adult and paediatric patients. It is not intended for use in mammography.
Device Description
In comparison to existing devices, the new detectors incorporate a Flexible a-Si in the TFT material within the panel. The primary difference from the conventional glass a-Si panel is that the electronic circuits, such as silicon, are deposited on a plastic substrate instead of a glass substrate during the manufacturing of the TFT panel. Since only the material of the substrate on which the silicon is deposited changes, the overall image performance remains unaffected. Another difference is the pixel pitch. While existing products feature only a pixel pitch of 140μm, the new models include an option with a pixel pitch of 100um. The resolution of an X-ray detector has a significant impact on MTF (Modulation Transfer Function) and sensitivity.
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K Number
K242591Device Name
XERO-alpha
Manufacturer
DRTECH Corporation
Date Cleared
2024-11-01
(63 days)
Product Code
EHD
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
DRTECH Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
XERO a is an Hand-held intraoral dental x-ray equipment to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients. This equipment is used in a professional healthcare facility environment.
Device Description
XERO a is an Hand-held intraoral dental x-ray equipment to produce X-ray images using intraoral image receptors. It is indicated for use by a dental technician for both adult and pediatric patients. This equipment is used in the professional healthcare facility environment. But the image detectors (an integral part of a complete dental system) are not part of the device. The operation principle of the device involves emitting x-ray source when a high voltage is supplied to the X-ray tube assembly, which frees electrons from the cathode. They hit anode to produce X-rays. The device acquires images by emitting X-rays continuously on the human tooth. And the functions of the dental generator XERO a are supported by firmware. This is of basic firmware documentation level, and there is no external data exchange port in the device. Moreover, the XERO a is not wireless. The subject dental system is not a cyber device.
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K Number
K242847Device Name
EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM); EXSYS DEXi (EXSYS DEXi-D401S-FRA); EXSYS DEXi (EXSYS DEXi-D402S-FRA); EXSYS DEXi (EXSYS DEXi-D401P-FRA); EXSYS DEXi (EXSYS DEXi-D402P-FRA);
Manufacturer
DRTECH Corporation
Date Cleared
2024-10-23
(33 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
DRTECH Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EXSYS DEXi is a diagnostic X-ray system intended for use in generating radiographic images of human anatomy for general purpose. The system obtains necessary information of patient's anatomical structure by an image processing (workstation) after process of examination using radiation exposure with DR. This system is not intended for mammography applications.
Device Description
The EXSYS DEXi is a diagnostic X-ray system intended for use in generating radiographic images of human anatomy for general purpose. The system obtains necessary information of patient's anatomical structure by an image processing (workstation) after process of examination using radiation exposure with DR. This system is not intended for mammography applications.
The EXSYS DEXi composed of a x-ray generator, tube, collimator, tube stand, bucky stand, patient table, flat panel detector and console.
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K Number
K240243Device Name
EConsole2
Manufacturer
DRTECH Corporation
Date Cleared
2024-09-23
(237 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DRTECH Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EConsole2 is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, and mammographic applications). It is intended for both adult and pediatric populations.
Device Description
EConsole2 is digital radiography operating console software. EConsole2 provides an integrated solution for X-ray projection. It integrates with the digital detector. Furthermore, EConsole2 acquires and processes images. In addition, it complies with DICOM standards and is able to transmit and receive data with the PACS system, and print images through the DICOM printer.
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K Number
K233530Device Name
EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DEXi-D503T-FRM); EXSYS DEXi (EXSYS DEXi-A503T-FRM)
Manufacturer
DRTECH Corporation
Date Cleared
2024-07-26
(267 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
DRTECH Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K232082Device Name
EXPD 4343S
Manufacturer
DRTECH Corporation
Date Cleared
2024-02-13
(215 days)
Product Code
MQB, MOB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
DRTECH Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EXPD 4343S Digital X-ray detector is indicated for use in generating radiographic images of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures on general populations. This device is not intended for mammography applications.
Device Description
The EXPD 4343S Detector is a square plate-shaped indirect conversion device that converts incoming X-rays into visible light. This visible light is subsequently captured by an optical sensor, which produces an electric charge representation of the spatial distribution of the incoming X-ray quanta. Through thin film transistors, the charges are transformed into a modulated electrical signal is amplified, then changed from an analog to digital form (from voltage to signal) so that it can be printed out, sent for remote viewing, or saved as an electronic data file for later viewing. The subject device features two matrix arrays strategically positioned in an overlapping configuration within the housing, facilitating the generation of multiple images with a single exposure. Array #1 works similarly to the predicate device by detecting incident X-ray photons and converting them into electrical signals. Simultaneously, Array #2 captures unabsorbed X-rays from Array #1 after passing through it. As a consequence of this configuration, the subject device has the capacity to produce three distinct images: a Standard image produced by Array #1, a second image (a soft tissue image) obtained by processing the Standard image using Console software, and a third image (a bone image) generated by processing the image obtained from Array #2.
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K Number
K232753Device Name
EXPD 4343D; EXPD 3643D
Manufacturer
DRTECH Corporation
Date Cleared
2023-11-16
(69 days)
Product Code
MQB
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
DRTECH Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EXPD 4343D and EXPD 3643D Digital X-ray detector are indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This devices are intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This devices are not intended for mammography applications.
Device Description
The EXPD 4343D, EXPD 3643D are flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-ray film or an image plate as an image capture medium. EXPD 4343D, EXPD 3643D differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form.
The EXPD 4343D, EXPD 3643D Detector are indirect conversion devices in the form of a square plate in which converts the incoming X-rays into visible light. This visible light is then collected by an optical sensor, which generates an electric charges representation of the incoming X-ray quanta.
The charges are converted to a modulated electrical signal thin film transistors. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing.
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K Number
K231225Device Name
EConsole1
Manufacturer
DRTECH Corporation
Date Cleared
2023-10-18
(173 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DRTECH Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EConsole1 is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, and mammographic applications).
The main features of this software are controlling and interfacing the detector, controlling the x-ray generator acquisition settings, storing acquired images, data management and image processing.
Device Description
Radiological Image Processing Software, EConsolel is complete digital image processing console software specialized for the digital X-ray detector series developed by DRTECH Corporation.
EConsole1 not only processes the acquired images but also complies with DICOM standards which allow the user to transmit and receive data with the PACS system and print images through the DICOM printer.
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