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510(k) Data Aggregation
K Number
K083917Device Name
X-RAY, TOMOGRAPHY, COMPUTED, DENTAL
Manufacturer
SUNI MEDICAL IMAGING, INC.
Date Cleared
2009-06-02
(154 days)
Product Code
OAS, LLZ, MUH
Regulation Number
892.1750Why did this record match?
Applicant Name (Manufacturer) :
SUNI MEDICAL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Suni3D is a computed tomography x-ray system, which is a diagnostic x-ray system intended to produce panoramic, cephalometric, and cross-sectional images for dental examination and diagnosis of diseases of the teeth, jaw and oral structures by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Device Description
Not Found
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K Number
K070219Device Name
SUNIRAY II DIGITAL RADIOGRAPHY SYSTEM
Manufacturer
SUNI MEDICAL IMAGING, INC.
Date Cleared
2007-02-07
(15 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SUNI MEDICAL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SuniRay II Digital Radiography System is used to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
Device Description
The Suni SuniRay II Digital Radiography System ("System") will produce real time digital intra-oral images with a reduction in X-ray dosages as compared to film. The System accomplishes this by replacing X-ray film with an electronic sensor that captures the X-ray photons and converts the photons to an electronic signal which in turn is captured in a computer for viewing, manipulating, storing, and outputting (printing or Email).
The System consists of two sensor versions (designated as #1 & #2 sizes; equivalent to dental film sizes), an attached USB electronics box that controls the sensor and interfaces to the computer USB port. The System also includes software drivers that control the USB electronics box, and a Graphical User Interface (GUI) that allows the user access to the data and control functions of the System.
The GUI used with the device was designed by Apteryx, Inc. who holds 510(k) K983111 for their product. Apteryx is responsible for both product validation and GMP compliance. The SuniRay II System software utilizes the Windows XP environment.
The System sensors are in two formats. The #2 size is a larger sensor typical of the European format and the # 1 size is an intermediate size. The sensors consist of a CMOS type integrated circuit, and a high resolution scintillator screen that converts the photons from the X-rays into visible light, which is then acquired by the CMOS imaging integrated circuit. The sensors are encapsulated with a three-foot cable that is connected to the USB electronics box.
The USB electronics box plugs into a computer USB port via a supplied USB cable. The USB electronics box contains the support and control circuitry for the sensor and allows for data communications with the computer. The USB electronics box contains all necessary circuits for sensor data acquisition as well as memory for firmware control of the CMOS X-ray sensor and USB. The USB electronics box communicates with the computer under control of a specific device driver that is active with the GUI.
The System software functions on three levels: (1) The computer operating system (Microsoft Windows) controls the computer, user interface, and file structure; (2) Primary control of the sensor and bus functions is achieved by proprietary software and is either embedded firmware or in non user accessible drivers; and (3) A Graphical User Interface (GUI) allows the user to control the x-ray function, control of the sensor data acquisition, and image viewing, manipulation and output. Examples of the GUI include image capture, enhanced viewing features (zoom, pan, colorize, contrast/brightness, comparative analysis, etc) image organization, and storage.
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K Number
K060149Device Name
SUNIPAN IMAGING SYSTEM & ACCESSORIES
Manufacturer
SUNI MEDICAL IMAGING, INC.
Date Cleared
2006-02-03
(14 days)
Product Code
MUH
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
SUNI MEDICAL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For diagnostic radiographic use in dental, oral surgery, and orthodontic practices.
Device Description
Axial rotation x-ray source (PC-1000). The PC-1000 panoramic X-ray machine portion of the Sunipan Imaging System generates the required ionizing radiation (x-rays) This unit is identical to the PC-1000 model supplied directly by Panoramic Corporation for use with standard x-ray film. The Sunipan Imaging System combines this base x-ray unit with an available aftermarket digital imaging sensor, creating a filmless digital imaging system.
Digital Image Sensor (Scan300fp/Retropan) is a high speed x-ray camera tailored for dental panographic applications. Originally designed and cleared for retro-conversion of existing standard panographic x-ray units. The sensor system utilizes direct conversion technology which offers a number of benefits over CCD technology. The images obtained may be reviewed and adjusted after exposure to focus on different layers or areas of clinical it rest.
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