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510(k) Data Aggregation
K Number
K091732Device Name
VRLXP, MODEL XP
Manufacturer
DEEP BREEZE LTD.
Date Cleared
2010-03-04
(266 days)
Product Code
OCR
Regulation Number
870.1875Why did this record match?
Product Code :
OCR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VRIxp is intended for monitoring and recording lung sounds and automatic detection of crackles and wheezes. When interpreted by physicians with general medical training and experience, the VRIxp aids in diagnosis and patient management. The VRIxp is intended to be used in healthcare facilities on adults, adolescents, and/or children over the height of 2 feet 9 inches.
Device Description
The VRIxp is a non-invasive, non-energy emitting device indicated for monitoring and recording lung sounds and automatic detection of crackles and wheezes. When interpreted by physicians with general medical training and experience, the VRIxP aids in diagnosis, monitoring, and patient management.
The VRIxp consists of same fundamental components as its predecessors the VRLE and the VRIxy, which are I) sound sensors designed to collect lung sounds via dermal contact with human skin; 2) a Digital Collection Module (DCM) for the conversion of analog data to digital data; and 3) a mobile computer workstation to assist in processing, displaying, and/or storing recording information.
During the breathing process, the VRIxp detects lung sounds (i.e., acoustic energy) and converts them into a visual display, which can be viewed via a personal computer (PC) monitor and stored for future review. The device is designed to record breath sounds based on sensor location. Additionally, the VRIxp has an automated feature for detecting sounds consistent with crackles and wheezes for further clinical evaluation. Lung sounds can be viewed collectively as a grayscale image, as well as audibly by sensor. This latter feature provides greater flexibility for physicians to validate visual lung data by applying his or her previous clinical experience with conventional auscultation (gold standard).
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K Number
K073582Device Name
VRIICU SYSTEM
Manufacturer
DEEP BREEZE LTD.
Date Cleared
2008-10-15
(300 days)
Product Code
OCR
Regulation Number
870.1875Why did this record match?
Product Code :
OCR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VRIxy is intended for use in monitoring and recording lung sounds.
Device Description
The modified VR Lung Electrosonograph, the VRIxy is intended for use in monitoring and recording lung sounds. The VRIxy is a non-invasive device designed to facilitate visualization and monitoring of regionally distributed vibration energy. The VRIxy is comprised of three primary components: 1) Electronic stethoscopes designed to collect lung sounds via dermal contact with the human thorax; 2) A Digital Collection Module ("DCM") for the conversion of analog data to digital data; and, 3) A mobile computer workstation to assist in processing, displaying, and/or storing recorded information.
The VRIxy represents a natural progression in the company's desire to improve bedside monitoring capabilities, and is designed to provide lung imaging capability in spontaneously breathing patients, as well as mechanically ventilated patients. In the latter, monitoring capabilities are enhanced by the synchronization of the VRIxy image and vibration energy graph, with the pressure and flow waveform sampled from a ventilator. All dynamic images can be viewed as video file or frame-by-frame. The vibration energy of the lungs can be depicted in grayscale or color. Patient recording and all associated data are stored in the VRIxy system. Current and/or previous recordings can be viewed side-by-side in order to compare patients' lung sound images during hospitalization. These recordings and associated reports can be viewed or exported for offline viewing or printed on a conventional PC computer.
The VRIxv is intended to be used by trained healthcare practitioners and has been designed to accommodate most clinic, treatment center, or hospital settings. The VRIxy is not intended to be used as a diagnostic instrument.
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K Number
K061495Device Name
VR LUNG ELECTROSONOGRAPH
Manufacturer
DEEP BREEZE LTD.
Date Cleared
2007-07-18
(413 days)
Product Code
OCR
Regulation Number
870.1875Why did this record match?
Product Code :
OCR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VR Lung Electrosonograph is intended for use in monitoring and recording lung sounds.
Device Description
The VR Lung Electrosonograph is intended for use in monitoring and recording lung sounds. The VR Lung Electrosonograph is a non-invasive device consisting of three primary components: 1) Electronic stethoscopes designed to collect lung sounds via dermal contact with the human thorax; 2) a Digital Collection Module ("DCM") for the conversion of analog data to digital data; and 3) a mobile computer workstation to assist in processing, displaying, and/or storing recorded information. The VR Lung Electrosonograph is intended to be used by trained healthcare practitioners, and has been designed to accommodate most clinic, treatment center, or hospital settings. While the VR Lung Electrosonograph may aid in diagnosis, the device is not intended to be used as a diagnostic instrument.
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