Search Results
Found 1 results
510(k) Data Aggregation
K Number
K133209Device Name
FORESEE (4C) IMAGING SYSTEM
Manufacturer
Date Cleared
2014-03-17
(151 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
DIAGNOSTIC PHOTONICS, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Foresee (4C) Imaging System is intended to be used as an imaging tool in the evaluation of external human tissue microstructure by providing two-dimensional, crosssectional, real-time depth visualization.
Device Description
The Foresee (4C) Imaging System uses optical coherence tomography (OCT) to create images of tissue. OCT is an imaging technology similar to ultrasound except that images are formed using reflected light rather than reflected sound. In place of sound waves, OCT uses a near-infrared beam of light that penetrates tissue. The light reflects off of changes in tissue microstructure. Using the principles of low-coherence interferometry, a technique that measures the interference of light from a sample arm and a reference arm to create an image, OCT produces a high-resolution depth profile. Scanning the beam across tissue produces a detailed, two-dimensional image of tissue microstructure morphology.
The Foresee (4C) Imaging System uses a broadband, swept optical source and a fixed reference arm to acquire imaging data in the frequency domain. The Foresee (4C) Imaging System has a handheid probe for the scanning of tissue. The probe has a fixed focal depth with a correction for beam diffraction employing a physics-based, software signal processing technique.
The Foresee (4C) Imaging System consists of a cart-mounted imaging console with an isolation transformer; a foot pedal; a handheld imaging probe with a single-use non-sterile disposable probe tip: an imaging module containing a light source, interferometer, and detector; and an imaging computer that implements physics-based software signal processing; and dual monitors for image display. The system user interface allows the viewing, capture, review and export of images.
Ask a Question
Ask a specific question about this device
Page 1 of 1