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Found 7 results
510(k) Data Aggregation
K Number
K103693Device Name
VANTAGE ABI
Manufacturer
SUMMIT DOPPLER SYSTEMS, INC.
Date Cleared
2011-02-15
(60 days)
Product Code
DXN
Regulation Number
870.1130Why did this record match?
Applicant Name (Manufacturer) :
SUMMIT DOPPLER SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vantage ABI is a non-invasive device used to gauge the lower extremity arterial system using pneumatic volume plethysmography recording (PVR) and oscillometric systolic blood pressure to assist in the diagnosis of vascular disease.
Device Description
The Vantage ABI performs the ankle-brachial index examination to assist in the diagnosis of peripheral arterial disease. The system will be used to assess peripheral arterial disease using pneumatic volume plethysmography recording (PVR), estimate the systolic blood pressure for each limb and calculate the Ankle Brachial Index. The unit will record a PVR waveform at each ankle and measure pressures in each limb. Four cuffs will be connected. This unit can be powered from its internal battery or from an external line-powered supply.
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K Number
K101816Device Name
STN PROBE
Manufacturer
SUMMIT DOPPLER SYSTEMS, INC.
Date Cleared
2010-08-19
(50 days)
Product Code
ITX
Regulation Number
892.1570Why did this record match?
Applicant Name (Manufacturer) :
SUMMIT DOPPLER SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
Device Description
The LifeDop is a hand-held, battery powered, audio Doppler device used for blood flow detection in veins and arteries: The product includes sterilizable detachable ultrasound transducer probe and user replaceable batteries. The user interface includes an on/off button, volume control, single 2-1/4" speaker and battery. The product is housed in custom injection molded housings. Patient contact materials are ABS and Ploycarbonate injection molded plastic.
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K Number
K093393Device Name
LIFEDOP MODEL 300ABI
Manufacturer
SUMMIT DOPPLER SYSTEMS, INC.
Date Cleared
2009-12-24
(55 days)
Product Code
JAF
Regulation Number
892.1540Why did this record match?
Applicant Name (Manufacturer) :
SUMMIT DOPPLER SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
Device Description
The LifeDop is a hand-held, battery powered, audio Doppler device used for blood flow detection in veins and arteries. The product includes two interchangeable ultrasound transducer probes and user replaceable batteries. The user interface includes an on/off button, volume control, 12 button keypad for entering pressure data and printing, single 2-1/4" speaker, and LCD display for displaying data, battery and waveform information. The product is housed in custom injection molded housings. Patient contact materials are ABS and Ploycarbonate injection molded plastic and hypoallergenic aqueous gel used for ultrasound transmission.
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K Number
K090499Device Name
LIFEDOP MODEL, L350R
Manufacturer
SUMMIT DOPPLER SYSTEMS, INC.
Date Cleared
2009-03-31
(34 days)
Product Code
MAA
Regulation Number
884.2660Why did this record match?
Applicant Name (Manufacturer) :
SUMMIT DOPPLER SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Obstetrical: This product will be used to detect fetal heart beats as an aid for determining fetal viability. Vascular: This product will also be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
Device Description
The LifeDop 350 Doppler is a portable, battery-powered ultrasound device used for detecting fetal heart beats and also for blood flow detection in veins and arteries. Primarily intended to be table-top, stand or wall mounted.
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K Number
K063600Device Name
VISTA AVS
Manufacturer
SUMMIT DOPPLER SYSTEMS, INC.
Date Cleared
2006-12-19
(15 days)
Product Code
JAF
Regulation Number
892.1540Why did this record match?
Applicant Name (Manufacturer) :
SUMMIT DOPPLER SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for detection of blood flow in veins and arteries and as an aid for the diagnosis of peripheral vascular disease.
Device Description
The Vista AVSTM is a diagnostic ultrasound device used to aid the clinician in obtaining systolic pressure values at the arms, legs and feet. The device will provide a bi-directional Doppler for detecting presence or absence of blood flow, and will control the inflation and deflation of a pressure cuff under direction of the user. Two additional modalities, Pulse Cuff Recording (PCR) and Photoplethysmography (PPG), will provide additional information for the clinician. PCR will be used as a plethysmograph to obtain alternative blood flow waveforms, and the PPG will be used primarily to obtain toe pressures. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has accepted or entered the appropriate pressure values. Waveforms, pressure values, and index results can be printed directly from the device or uploaded using AVS ReportTM report generating software and an external user supplied PC via a USB port. The unit can run from an internal power source or from an external power supply, and mounts to a rolling stand.
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K Number
K060410Device Name
ECHOHEART TRANSVAGINAL DOPPLER PROBE
Manufacturer
SUMMIT DOPPLER SYSTEMS, INC.
Date Cleared
2006-04-10
(53 days)
Product Code
HEK
Regulation Number
884.2660Why did this record match?
Applicant Name (Manufacturer) :
SUMMIT DOPPLER SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This product will be used to detect fetal heart tones transvaginally as an aid for determining fetal viability.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transvaginal (N= new indication)
Device Description
The EchoHeart Transvaginal Doppler is an interchangeable transvaginal Doppler probe used with the handheld LifeDop Doppler System. It is designed for more consistent determination of fetal viability in difficult examinations when a standard transabdominal probe is insufficient - such as early gestations. obese patients and retroverted uterine positions.
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K Number
K024197Device Name
LIFEDOP DOPPLER
Manufacturer
SUMMIT DOPPLER SYSTEMS, INC.
Date Cleared
2003-01-03
(14 days)
Product Code
KNG
Regulation Number
884.2660Why did this record match?
Applicant Name (Manufacturer) :
SUMMIT DOPPLER SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Obstetric (2.1 and 3.2 MHz Probes) This product will be used to detect fetal heart beats as an aid for determining fetal viability.
Vascular (4.0 and 8.0 MHz Probes) This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.
Diagnostic ultrasound Imaging or fluid flow analysis of the human body as follows: Fetal (Mode of Operation: CWD); Peripheral Vascular (Mode of Operation: CWD)
Device Description
The LifeDop is a hand-held, battery powered, audio Doppler device used for detecting fetal heart beats and for blood flow detection in veins and arteries. The product includes four interchangeable probes (OB Late Term, OB Early Term, Vascular pencil probe, Vascular flat face probe) and user replaceable batteries. The user interface includes an on/off button, play/record button, volume control, single 2-1/4" speaker, headphone jack and LCD display for heart rate, battery and waveform information.
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