Search Results
Found 2 results
510(k) Data Aggregation
K Number
K123216Device Name
AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN
Manufacturer
AIMAGO SA
Date Cleared
2013-02-07
(115 days)
Product Code
DPT
Regulation Number
870.2120Why did this record match?
Applicant Name (Manufacturer) :
AIMAGO SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aïmago EasyLDI Microcirculation Camera is intended for blood flow measurements in the microcirculation. In particular, it can be used for measuring perfusion of healthy and injured skin including burn wounds, skin flaps (plastic and reconstructive surgery) and hand surgery.
EasyLDI Studio is intended to be used as offline viewer application for snapshots, videos and references recorded with the Aïmago EasyLDI Microcirculation Camera.
Device Description
The Aïmago EasyLDI microcirculation camera is a device for imaging blood flow in the microcirculation. It is a medical diagnostic imaging device which serves to visualize the perfusion of cutaneous microcirculation in the form of arbitrary units in real-time. The EasyLDI uses the established laser Doppler technique performing a 2-dimensional area scan to build up a color coded image of the blood flow in the tissue. In the form of arbitrary units, this image allows the surgeon to quantify movement of blood cells beneath the skin surface.
The software changes implemented in the Aïmago EasyLDI microcirculation camera V2.X allow the user different modes of displaying the information on the built-in screen, thus facilitating the assessment of the microcirculation patterns for the specified applications.
EasyLD! Studio is a standalone software which runs on Windows systems. It is an optional accessory to the Aïmago EasyLDI microcirculation camera. It can be used to view LDI items (i.e. LDI snapshots, videos or references previously recorded with the Aïmago EasyLDI) on a commercially available desktop computer.
Ask a Question
K Number
K121429Device Name
AIMAGO EASYLDI MICROCIRCULATION CAMERA
Manufacturer
AIMAGO SA
Date Cleared
2012-08-10
(88 days)
Product Code
DPT
Regulation Number
870.2120Why did this record match?
Applicant Name (Manufacturer) :
AIMAGO SA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aimago EasyLDI Microcirculation Camera is intended for blood flow measurements in the microcirculation.
Device Description
The Aimago EasyLDI microcirculation camera is a device for imaging blood flow in the microcirculation. It uses the established laser Doppler technique to quantify movement of blood cells beneath the skin surface. Unlike the predicate devices, the EasyLDI performs a 2dimensional Laser Doppler area scan to build up a color coded image of blood flow more rapidly than either predicate device.
Ask a Question
Page 1 of 1