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510(k) Data Aggregation
K Number
K211014Device Name
Portray
Manufacturer
Date Cleared
2021-07-28
(114 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
Surround Medical Systems
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Portray System is an extraoral X-ray source (intraoral X-ray system for producing diagnostic dental radiographs of the teeth, jav, and other oral structures. The system provides 2D imaging for diagnostic purposes and 3D imaging as an adjunctive tool.
Device Description
The Portray System, an extraoral X-ray source (intraoral X-ray detection) dental X-ray system, is a nanotechnology-based 2D and 3D extraoral imaging system offering high resolution X-ray image quality and diagnostic accuracy. The 3D image provides a layer-by-layer virtual dissection of the oral cavity when viewed as Tomosynthesis. Alternatively, when viewed as Synthetic 2D, the image provides a rotatable representation of a 2D image taken from the same point in space. 3D images are to be used only as an adjunct to 2D image analysis.
The Portray System is comprised of the following components:
- Computer ●
- User Interface Software ●
- High voltage Electronics ●
- Wall-mount ●
- Articulating Arm .
- X-ray Source Array (Tube) .
- . X-ray Shielding
- X-ray Collimator ●
- Detector Holder ●
- . Intraoral X-ray Detector
The Portray Detector Holder and off-the-shelf detector sleeve are accessories to the Portray System and the sole patient contacting components.
The Portray system will be available in a single, wallmounted configuration.
The Portray system software will support interoperability with electronic patient records and storage of X-ray images in a persistent database located on a Local Area Network (LAN).
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