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510(k) Data Aggregation
K Number
K230448Device Name
DeepX DermoSight Dermatoscope
Manufacturer
DeepX Health LLC
Date Cleared
2023-05-17
(85 days)
Product Code
PSN
Regulation Number
878.4580Why did this record match?
Product Code :
PSN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DeepX DermoSight Dermatoscope is a non-invasive skin imaging system, which acquires white light dermatoscopic images and clinical photographs of the skin. These can be stored, retrieved, displayed and reviewed by trained medical practitioners.
Device Description
The DeepX Health DermoSight Dermatoscope is designed to acquire images of the skin and optimize the imaging storage and documentation workflow. The DeepX Health DermoSight Dermatoscope system consists of a hardware device and a software application. The hardware device is a hand-held, dermatoscope (camera) for acquiring and transmitting images of the skin. The hand-held, portable unit includes an LED light-source, a digital camera and a USB cable to transfer images to a standard PC workstation. The device acquires optical dermatoscopic images in a contact mode (acquired with the device in contact with the skin). In addition, the device can also acquire a clinical close-up image, when it is positioned 15cm from the skin.
The stand-alone software application is cloud-based software with a related web application. The cloud software allows for storage and retrieval of the acquired images and patient data for review by medical professionals.
DeepX Health DermoSight Dermatoscope software is a stand-alone application to be accessed via a standard computer connected to the hospital/clinic server or directly to the internet.
The software displays the patient demographic and identification information (e.g., date of image acquisition and anatomic location of photographed site). The images and identification data may be output to the computer used for image acquisition or downloaded to an alternate computer or storage device identified by the user.
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K Number
K213957Device Name
Demetra Dermatoscope BDEM-01
Manufacturer
Barco NV
Date Cleared
2022-03-11
(84 days)
Product Code
PSN
Regulation Number
878.4580Why did this record match?
Product Code :
PSN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Barco Digital Dermatoscope is a non-invasive skin imaging system, which acquires multispectral and white light dermoscopic images and clinical photographs of the skin. These can be stored, retrieved, displayed and reviewed by trained medical practitioners.
Device Description
The Barco Demetra BDEM-01 is designed to capture images of the skin and optimize the imaging and documentation workflow. The “Barco Demetra BDEM-01” consists of a hardware device and a software application. The hardware device is a portable, battery powered medical device for acquiring and visualizing images of the skin. The device acquires multispectral optical dermoscopic images in a contact mode (device in contact with the skin). In addition, the device can also acquire a clinical close-up image, when it is held at up to 10 to 15 cm from the skin, and a clinical overview image when it is held at a distance of approximately 35-55 cm from the skin. The stand-alone software application is cloud software with a related web application. The cloud software can generate reports containing white light dermoscopic images and clinical photographs of the skin to be reviewed by trained medical practitioners.
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K Number
K201408Device Name
Demetra Analytics Toolkit
Manufacturer
Barco NV
Date Cleared
2021-02-18
(266 days)
Product Code
PSN
Regulation Number
878.4580Why did this record match?
Product Code :
PSN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Barco Demetra Analytics Toolkit is a non-invasive skin analysis system. The Barco Demetra Skin Parameter Maps Tool provides maps that show the relative location of blood and pigment. The Barco Demetra Skin Parameter Maps Tool is intended only to complement dermoscopy.
Device Description
The Barco Demetra Analytics Toolkit is a software application used to support analysis of dermoscopic images captured with the Barco Demetra BDEM-01 dermatoscope (K192829). The system is intended for use by medical practitioners. Scatter Contrast Maps provide additional information to dermoscopy by highlighting surface contours. The Skin Parameter Maps Tool provides images generated from multispectral image sets and aids the user in visualizing blood and pigment patterns in the skin. The output of the Skin Parameter Maps is shown to the user as grayscale two-dimensional maps. The maps are intended only to complement dermoscopy.
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K Number
K192829Device Name
Demetra BDEM-01 Dermatoscope
Manufacturer
Barco NV
Date Cleared
2019-12-13
(72 days)
Product Code
PSN
Regulation Number
878.4580Why did this record match?
Product Code :
PSN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Barco Digital Dermatoscope is a non-invasive skin imaging system, which acquires multispectral and white light dermoscopic images and clinical photographs of the skin. These can be stored, retrieved, displayed and reviewed by trained medical practitioners.
Device Description
The Barco Demetra BDEM-01 is designed to capture images of the skin and optimize the imaging and documentation workflow. The “Barco Demetra BDEM-01” consists of a hardware device and a software application. The hardware device is a portable, battery powered medical device for acquiring and visualizing images of the skin. The device acquires multispectral optical dermoscopic images in a contact mode (device in contact with the skin). In addition, the device can also acquire a clinical close-up image, when it is held at up to 10 to 15 cm from the skin, and a clinical overview image when it is held at a distance of approximately 35-55 cm from the skin. The stand-alone software application is cloud software with a related web application. The cloud software can also generate one or more reports and feedback to the device.
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K Number
K180162Device Name
VivaScope System
Manufacturer
Caliber Imaging & Diagnostics, Inc.
Date Cleared
2018-05-03
(104 days)
Product Code
PSN
Regulation Number
878.4580Why did this record match?
Product Code :
PSN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VivaScope® System is intended to acquire, store, retrieve, display and transfer in vivo images of tissue, including blood, collagen and pigment, in exposed unstained epithelium and the supporting stroma for review by physicians to assist in forming a clinical judgment.
Device Description
The VivaScope® System is a reflectance confocal microscope, full color macroscopic imager, and software that captures images of in vivo tissue specimens from the exposed surface of the tissue, through the unstained epithelium and into the superficial supporting stroma. It provides non-invasive in vivo images of the epithelium and supporting stroma. The VivaScope® System does NOT provide automated analysis or diagnosis of the images it produces. It is capable of imaging cells in the epidermis of skin and the fibrous tissue (primarily collagen and fibrin) in the dermis. In addition, it is possible to visualize circulation of blood cells (including both erythrocytes and leukocytes) in capillaries and other small vessels.
The VivaScope® System produces horizontal sections of the skin using safe. low power infrared laser light at nominal wavelength of 830 nm (CDRH laser Class 1). Horizontal sections make it straightforward to view the various lavers of the skin in sequence, from the outer surface of the stratum corneum, through the granular, spinous and basal lavers, to the level of the superficial reticular dermis.
The VivaScope® System produces high resolution images of the skin using confocal laser scanning microscopy. The key feature of confocal microscopy is the ability to produce in-focus images of thick specimens called "optical sectioning". The system is able to accomplish this by having the point source laser light, the illuminated spot in the sample, and the pinhole all lie in optically conjugate focal planes. The size of the pinhole (located in front of the photodiode) is matched to the size of the illuminated spot to reject out of focus light allowing for imaging of thin optical sections.
The VivaScope® System can image, display, store, retrieve, import and export in vivo confocal and macroscopic color images using the VivaScan® operating software and supporting PC hardware. Images are saved and stored using standard lossless image compression algorithms. Images are communicated to other devices using DICOM standard functionality that is incorporated into the VivaScan® operating software.
The VivaScope® System is comprised of four (4) major functional components: an imager, a display, a PC and a cart. A VivaScope® System will have either a VivaScope® arm mounted imaging head or a VivaScope® handheld imaging head, or both, and optionally, a VivaCam® full color macroscopic imaging head.
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K Number
K080788Device Name
VIVASCOPE SYSTEM, MODEL 1500, 3000
Manufacturer
LUCID, INC.
Date Cleared
2008-09-17
(181 days)
Product Code
PSN, FSS
Regulation Number
878.4580Why did this record match?
Product Code :
PSN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VivaScope® System is intended to acquire, store, retrieve, display and transfer in vivo images of tissue, including blood, collagen and pigment, in exposed unstained epithelium and the supporting stroma for review by physicians to assist in forming a clinical judgment.
Device Description
The VivaScope System is a reflectance confocal microscope, full color macroscopic imager, and software that captures images of in vivo tissue specimens from the exposed surface of the tissue, through the unstained epithelium and into the superficial supporting stroma. It provides non-invasive in vivo images of the epithelium and supporting stroma. The VivaScope® System does NOT provide automated analysis or diagnosis of the images it produces. It is capable of imaging cells in the epidermis of skin and the fibrous tissue (primarily collagen and fibrin) in the dermis. In addition, it is possible to visualize circulation of blood cells (including both erythrocytes and leukocytes) in capillaries and other small vessels.
The VivaScope System produces horizontal sections of the skin using safe, low power infrared laser light at nominal wavelength of 830 nm (CDRH laser Class I). Horizontal sections make it straightforward to view the various layers of the skin in sequence, from the outer surface of the stratum comeum, through the granular, spinous and basal layers, to the level of the superficial reticular dermis.
The VivaScope® System produces high resolution images of the skin using confocal laser scanning microscopy. The key feature of confocal microscopy is the ability to produce in-focus images of thick specimens called "optical sectioning". The system is able to accomplish this by having the point source laser light, the illuminated spot in the sample, and the pinhole all lie in optically conjugate [ocal planes. The size of the pinhole (located in front of the photodiode) is matched to the size of the illuminated spot to reject out of focus light allowing for imaging of thin optical sections.
The VivaScope® System can image, display, store, retrieve, import and export in vivo confocal
and macroscopic color images using the VivaScan operating software and supportin hardware. Images are saved and stored using standard lossless image compression algorithms. Images are communicated to other devices using DICOM standard functionality that is incorporated into the VivaScan® operating software.
The VivaScope® System is comprised of four (4) major functional components: an imager, a display, a PC and a cart. A VivaScope® System will have either a VivaScope® arm mounted imaging head or a VivaScope® handheld imaging head, or both, and optionally, a VivaCam® full color macroscopic imaging head.
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K Number
K062736Device Name
SIASCOPE V
Manufacturer
ASTRON CLINICA LIMITED
Date Cleared
2007-09-14
(366 days)
Product Code
PSN
Regulation Number
878.4580Why did this record match?
Product Code :
PSN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SIAscope is a non-invasive skin analysis system, which provides color bitmaps called 'SIAscans' that show the relative location of blood, collagen and pigment.
CAUTION : This device should only be used to scan the patient's skin.
Device Description
The SIAscope is a quick, non-invasive device for imaging skin conditions. It uses a technique known as 'Spectrophotometric Intracutaneous Analysis' (SIAscopy) to identify and display graphically the separate components of the skin. SIAscopy uses a digital camera and light (both visible and near-infrared) to investigate the skin's interior structure.
The SlAscope operates by illuminating the skin with LEDs and measuring the intensity of remitted light. The intensity of the illumination is similar to the emission from a typical hand held torch or remote control unit.
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K Number
K040171Device Name
MICRODERM, MODEL/VERSION 3.5
Manufacturer
VISIOMED AG
Date Cleared
2004-06-08
(134 days)
Product Code
PSN, LLZ
Regulation Number
878.4580Why did this record match?
Product Code :
PSN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MicroDERM® is intended for the acquisition and storage of images of skin surfaces. These images can then be retrieved, printed, reviewed and displayed.
Device Description
MicroDERM® is a digital dermascope and software system, which captures images of skin surfaces for physician diagnostic review and referral purposes. These images can be sent to other computers using a modem or network card. It consists of the MicroDERM® camera, MicroDERM® software, and a frame grabber card. The MicroDERM® software runs under the Microsoft® Windows 2000 operating system. MicroDERM is not intended as a diagnostic device.
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K Number
K023729Device Name
SIASCOPE II
Manufacturer
ASTRON CLINICA LIMITED
Date Cleared
2003-02-03
(89 days)
Product Code
PSN
Regulation Number
878.4580Why did this record match?
Product Code :
PSN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SIAscope is a non-invasive skin analysis system, which provides a synthesized 'image' showing the relative location of blood collagen and pigment.
Device Description
SIAscope is a non-invasive skin analysis system.
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K Number
K011273Device Name
SI ASCOPE
Manufacturer
ASTRON CLINICA LIMITED
Date Cleared
2002-02-20
(300 days)
Product Code
PSN
Regulation Number
878.4580Why did this record match?
Product Code :
PSN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SIAscope is a self -contained non-invasive skin analysis system, which provides a synthesized 'image' showing the relative location of blood, collagen and pigment.
Device Description
SIAscope is a self -contained non-invasive skin analysis system, which provides a synthesized 'image' showing the relative location of blood, collagen and pigment.
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