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Found 30 results
510(k) Data Aggregation
K Number
K243420Device Name
HESTIA
Manufacturer
GENORAY Co., Ltd.
Date Cleared
2025-07-17
(255 days)
Product Code
MUE
Regulation Number
892.1715Why did this record match?
Applicant Name (Manufacturer) :
GENORAY Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K251109Device Name
SMARTDent
Manufacturer
RAY Co., Ltd.
Date Cleared
2025-05-21
(40 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
RAY Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SMARTDent is intended for use as a software solution for managing dental diagnostic images and providing tools to support diagnosis.
Device Description
SMARTDent provides the function to efficiently manage CT, panorama, cephalometric, intraoral sensor images and intraoral camera images acquired using X-ray imaging equipment of Ray Co., Ltd. and performs various image analysis according to the diagnostic purposes.
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K Number
K241996Device Name
ULTRA 1040
Manufacturer
ECORAY Co., Ltd.
Date Cleared
2025-04-18
(283 days)
Product Code
IZL
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
ECORAY Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ULTRA 1040 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the patient's extremities.
This device is not intended for mammography.
Device Description
This Portable X-ray Unit (Model: ULTRA 1040) consists of the following major components: an X-ray main unit, an X-ray exposure hand switch and a battery charger and other components. The X-ray main unit is mainly for emitting X-rays required for X-ray exams; the hand switch is for output control of X-ray emitting, and the battery charger is for charging the built-in battery in the X-ray main unit. The device can be used with an X-ray detector, a computer for receiving and detecting signal results and image processing software. The major components of the X-ray main unit include: handle, enclosure, control panel, system control board, high-voltage tank, collimator (beam limiter), lithium-ion battery and system control software running on the system control board.
The system control software is for real-time interaction and control with various circuit modules inside the portable X-ray unit. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board and control the high-voltage tank to generate high-voltage to excite the ray tube inside to emit X-rays, control the switch of the collimator indicator, and monitor the working status of the device, the battery power status, and control the display of the status indicators.
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K Number
K243903Device Name
RCT600
Manufacturer
RAY Co., Ltd.
Date Cleared
2025-03-12
(83 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
RAY Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RCT600 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus and TMJ structure for adult and pediatric patients. Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment. The device is to be operated and used by dentists or other legally qualified heath care professionals.
Device Description
RCT600 provides 3D computed tomography for scanning hard tissues such as bone and teeth. By rotating the C-arm, which houses a high-voltage generator, an X-ray tube and a detector on each end, CBCT images of dental maxillofacial structures are obtained by recombining data scanned from the same level at different angles. Functionalities include panoramic image scanning for obtaining images of whole teeth, and a cephalometric option for obtaining cephalometric images.
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K Number
K233625Device Name
RAYDENT SW
Manufacturer
RAY Co., Ltd.
Date Cleared
2024-05-16
(185 days)
Product Code
PNN, NOF
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
RAY Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RAYDENT SW is a software designed to assist dental professionals in planning patient treatment devices. The software performs simulations based on patient images, allowing reference to treatment plans, and is used as a tool to design treatment devices based on 3D mesh data. Treatment devices include prosthetic devices (Veneer, Crown, Bridge, In/Onlay) and orthodontic devices (Clear Aligner).
To use RAYDENT SW, users must have the necessary education and domain knowledge in orthodontic practice and receive dedicated training in the use of the software.
Device Description
RAYDENT is a software that provides tools to simulate treatment plans based on patient images generated by compatible scanners and design treatment devices based on appropriate three-dimensional images. It allows dental offices to acquire patient data in conjunction with software on compatible imaging equipment and utilize the acquired images to create treatment plans and devices for skilled dentists and oral and maxillofacial specialists.
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K Number
K232325Device Name
RAYSCAN a-Expert
Manufacturer
Ray Co., Ltd.
Date Cleared
2024-04-18
(259 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Ray Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RAYSCAN a- P, SC, OCL, OCS panoramic X-ray imaging system with Cephalostat is an extra-oral source X-ray system, intended for dental radiographic examination of the teeth, jaw, and oral structures, to include panoramic examinations and implantology and for TMJ studies and cephalometry. Images are obtained using the standard narrow beam technique.
Device Description
RAYSCAN α-Expert (RAYSCAN α-P, SC, OCL, OCS) provides panoramic for scanning teeth, jaw and oral structures. By rotating the C-arm, which houses a high-voltage generator, an all-in-one Xray tube and a detector on each end, panoramic images of oral and maxillofacial structures are obtained byrecombining data scanned from different angles. Functionalities include panoramic image scanning for obtaining images of whole teeth, and a Cephalometric scanning option for obtaining Cephalic images.
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K Number
K232158Device Name
GenX-CR
Manufacturer
Genoray Co., Ltd.
Date Cleared
2023-09-13
(55 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Genoray Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GenX-CR is a digital radiographic scanner for dental diagnostics intended for use by dentists and other qualified professionals.
This device is used to create and display digital images by scanning intraoral X-ray images stored in an Image Plate (or Phosphore Storage Plate).
Device Description
GenX-CR scans a reusable phosphor storage plate (hereinafter referred to as "PSP") instead of an analog film to acquire high-quality digital radiographic images, digitally processes them, and displays images on the equipment's touch display screen and computer screen. It's a scanner. PSP is also known as IP (Image Plate)
After scanning the PSP, the image is saved in the device's internal memory, the scanned image can be checked in advance through the touch display, and the image stored in the PSP can be deleted and the PSP can be ejected. Scanned images can be directly transmitted to a computer or network via an Ethernet cable and are used in PortView, a dental diagnostic software package, and other diagnostic software.
GenX-CR is composed of mainly consists of PSP Scanner, PSP tray, power adapter and cable, Ethernet cable, PSP transfer box, PSP, PSP Protective Cover, Hygenic Bag, Dental PSP scanner control system software (Version: V2.2)
GenX-CR contains firmware that is part of the system. And we hereby certify that the level of concern for this software(PortView) and firmware(GenX-OP) is of Moderate level of concern. And It has not been cleared with other predicate devices but is the initial used in GenX-CR
Its compact design allows installation in space-constrained locations and minimizeds operating costs by using a low-cost, reusable PSP.
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K Number
K232287Device Name
RAYSCAN a-Expert3D
Manufacturer
Ray Co., Ltd.
Date Cleared
2023-08-31
(30 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Ray Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RAYSCAN a-Expert3D, panoramic x-ray imaging system with cephalostat, is an extra-oral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBCT technique, to generate dentomaxillofacial 3D images.
Device Description
RAYSCAN α-3D, SM3D, M3DS and M3DL are 3D computed tomography for scanning hard tissues like bone and teeth. By rotating the C-arm, which houses a high-voltage generator, a X-ray tube and a detector on each end, CBCT images of dental maxillofacial structures are obtained by recombining data scanned from the same level at different angles. Functionalities include panoramic image option and cephalometric option.
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K Number
K230787Device Name
Oscar 15 & Oscar 15i
Manufacturer
Genoray Co., Ltd.
Date Cleared
2023-07-20
(120 days)
Product Code
OWB, JAA
Regulation Number
892.1650Why did this record match?
Applicant Name (Manufacturer) :
Genoray Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OSCAR 15 & OSCAR 15i are a mobile fluoroscopy system designed to provide fluoroscopic and spot film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, neurologic, vascular, cardiac and critical care. The system may be used for other imaging applications at the physician's discretion. OSCAR 15i are indicated only for adult patients.
Device Description
The OSCAR 15 & OSCAR 15i, C-Arm Mobile are used for providing fluoroscopic and radiographic images of patient anatomy, especially during special procedures in a hospital or medical clinics. The fluoroscopic mode of operation is very useful to the attending physician to see the images on real time without the need to develop individual films. These devices are intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. The OSCAR 15 & OSCAR 15i consist of the X-ray tube assembly, X-ray controller, Image receptor and some accessories with no wireless function. The difference between OSCAR 15 and OSCAR 15i is only image acquisition parts. (An Flat Panel Detector (FPD) is applied to OSCAR 15, and an Image instensifier is applied to OSCAR 15i.)
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K Number
K230753Device Name
RCT800
Manufacturer
Ray Co., Ltd.
Date Cleared
2023-04-11
(25 days)
Product Code
OAS
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
Ray Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RCT800 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric patients. And a model scan is included as an option. Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment. The device is to be operated and used by dentists or other legally qualified health care professionals.
Device Description
The system's purpose is RCT800, a 3D computed tomography scanner for scanning hard tissues like bones and teeth. By rotating the c-arm, which is embedded with an all-in-one x-ray tube and a detector on each end, CBCT images of the dental maxillofacial area can be attained by recombining data from the same level that is scanned from different angles. Additionally, the system includes a panoramic image scanning function for attaining images of the whole teeth, a cephalometric scanning option for attaining a cephalic image, and a Model Scan option for attaining a dental model CBCT image.
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