Search Results

The Laminar P1 device is a wearable and disposable, ultrasound-based (4.5 MHz, continuous-wave) patch sensor designed to detect blood flow in peripheral vessels and assist in the detection of peripheral vascular disease. The Laminar P1 device is intended to be used by medical professionals, such as physicians and nurses, in hospitals, clinics and private offices and healthcare facilities. It is to be used on adults, ages 18 years and older.

The Laminar P1 is an ultrasound-based battery-powered sensor patch designed to detect blood flow in veins and arteries to assist in the detection of peripheral vascular disease. The Laminar P1 consists of a single use sensor patch, a single use patch frame, and a reusable processing unit. The sensor patch is designed to have the same performance characteristics as traditional ultrasound transducer probes (4.5 MHz frequency) but in a patch form factor that is easy to place on the patient's body for a given time period. The patch frame is a sticky frame that aids in the positioning and alignment of the processing unit. The processing unit controls the piezoelectric transducers in the sensor patch and has a built-in speaker with volume-control, like the traditional handheld Doppler devices, and operates in the Doppler continuous-wave mode (4.5 MHz frequency). The Processing Unit is battery-operated.

The THD Revolution is intended to be used for the surgical treatment of hemorrhoidal disease. This treatment is based on the Doppler-guided Transanal Haemorrhoidal Dearterialization technique. The technique consists of locating and ligating the terminal branches of the superior haemorrhoidal artery using the THD Revolution device and the compatible single-use THD kits. THD Revolution and its accessories may exclusively be used by specialist physicians for ligation of the terminal branches of the superior haemorroidal artery in hospital facilities (or suitable aseptic outpatient facilities). Furthermore, by using the optic fiber accessory of the THD Revolution, it can be used in modality "Light Source", to support the different THD diagnostic devices.

Identically to the predicate devices K090009, K081429 e K070815, the THD Revolution is a 8 MHz continuous wave (CW) Doppler detector with a loudspeaker and a light source. Further, as the predicate device, the THD Revolution doppler is used with dedicated accessories (optical fiber and pneumatic foot pedal) and a dedicated kit containing a proctoscope, needle holder, knot tightener, sutures, doppler probe and Surgy proctoscope in order to allow the surgical operation through the Transanal Hemorroidal Dearterialization (THD) technique.

The simpleABI is a diagnostic ultrasound system used to aid a physician in obtaining systolic pressure values at the arms and legs to aid in the diagnosis of vascular disease. The system utilizes a handheld Doppler for detecting presence or absence of blood flow. The user, using a handheld aneroid, Doppler, and standard blood pressure cuffs, measures the systolic pressures of the arms and legs. Two additional modalities, Pulse Volume Recording (PVR) and Photoplethysmography (PPG), may optionally provide additional information for the clinician. PVR is a plethysmograph to measure the change in limb volume related to each cardiac pulse. The PPG may be used to obtain toe pressures as an optional method if arterial flow using a Doppler is problematic. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has entered the appropriate pressure values read from the handheld aneroid. Waveforms, pressure values, and index results can be printed directly from the system. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular. The 5MHz, 8MHz, or PPG probes are designed for peripheral vascular applications. The nominal 5MHz probe previously submitted and approved under K090465. The nominal 8MHz probe previously submitted and approved under K090465. The PPG probe is intended for vascular applications to determine blood flow in digits.

The simpleABI is a diagnostic ultrasound system. The system consists of a main body and one probe. The system utilizes a handheld Doppler for detecting presence or absence of blood flow. The user, using a handheld aneroid, Doppler, and standard blood pressure cuffs, measures the systolic pressures of the arms and legs. Two additional modalities, Pulse Volume Recording (PVR) and Photoplethysmography (PPG), may optionally provide additional information for the clinician. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has entered the appropriate pressure values read from the handheld aneroid. Waveforms, pressure values, and index results can be printed directly from the system.

This product will be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

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.

The THD Slide One Doppler guided proctoscope is a system for the surgical treatment of the hemorrhoids of second and third degree. It is based on Transanal Hemorrhoidal Dearterialization technique guided by a Doppler system, placed inside the THD Evolution Doppler device, is used to detect the terminal branch of the superior hemorrhoid artery, in order to perform ligation with a THD proctoscope, sutures and a needle holder included in the THD Kits. The THD Slide One is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.

The THD Slide One consists of the THD Evolution Doppler device and the THD Slide One Kt. The THD Evolution Doppler device is an 8 MHz continuous wave (CW) Doppler detector with loudspeaker and a power light source. The THD Evolution Doppler is used with dedicated accessories (Doppler transducer, optical fibers and pneumatic foot pedal), in order to facilitate surgical operation. The THD Slide One Kit is a sterilized surgical kit comprised of a proctoscope, needle holder, knot tightener, sutures and Doppler probe. The kits used for the surgical treatment could be the THD Slide One kit or one of the kits already cleared by THD/G.F .; the THD kit that was included in the THD Submission (K070815) or the THD Slide (K081429)

The THD Slide Doppler guided proctoscope is a system for the surgical treatment of the hemorrhoids of second and third degree. It is based on Transanal Hemorrhoidal Dearterialization technique guided by a Doppler probe. The Doppler system, placed inside the THD Evolution Doppler device, is used to detect the terminal branch of the superior hemorrhoid artery, in order to perform ligation with a THD Slide proctoscope, sutures and a needle holder included in the THD Slide Kit. The THD Slide is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.

The THD Slide consists of the THD Evolution Doppler device and the THD Slide Kit. The THD Evolution Doppler is an 8 MHz continuous wave (CW) Doppler detector with loudspeaker and a power light source. The THD Evolution Doppler is used with dedicated accessories (Doppler transducer, optical fibers and pneumatic foot pedal), in order to facilitate surgical operation. The THD Kit is a sterilized surgical kit comprised of a proctoscope, a needle holder, a knot tightener and sutures.

The THD Evolution Doppler guided proctoscope is a system for the surgical treatment of the hemorrhoids of second and third degree. It is based on Transanal Hemorrhoidal Dearterialization technique guided by a Doppler systems, placed inside the THD Evolution device, is used to detect the terminal branch of the superior hemorrhoid artery, in order to perform ligation with a proctoscope, sutures and superior holder included in the THD Kit. The THD is to be used by physicians in hospitals, clinics, and physician's offices by prescription or doctor's orders.

The THD consists of the THD Evolution Doppler Device and the THD Kit. The THD Evolution Doppler is a 8 MHz continuous wave (CW) Doppler detector with loudspeaker and a power light source. The THD Evolution Doppler must be used with dedicated accessories (Doppler transducer, optical fibers and pneumatic foot pedal), in order to facilitate surgical operation. The THD Kit is a sterilized surgical kit comprised of a proctoscope, sutures, a needle holder and a knot tightener.

This device is intended for detection of blood flow in veins and arteries and as an aid for the diagnosis of peripheral vascular disease.

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.

Diagnostic ultrasound blood flow detection of the human body. The Stethoflux is designed for use by general practitioners or specialists on their own responsibility. It allows dual stethoscopic and doppler peripheral vascular investigation in a simple auscultation. It facilitates: - the detection of blood-flow in the peripheral arteries - Systolic Blood Pressures (SBP) measurements of the lower limb and upper-limb in order to determine the possible PAD ankle Brachial index (ABI) in the concerned limb. when associated with a sphygmomanometer

Acoustic stethoscope with ultrasonic transducer. It operates with 2 modes stethoscopic mode (classical stethoscope) and Doppler mode. Powered by one (6LR61) 9V lenium battery. Doppler frequency: 8 MHz. Operating time 25 h according to use. Mass 331 g.

The Model 500H Doppler Guided Proctoscope is used to detect blood vessels supplying hemorrhoids and for performing HAL ( Hemorrhoid Arterial Ligation) for Class II and Class III hemorrhoids. It is to be used by physicians in hospitals, clinics, and physician's offices by prescriptions or doctor's orders.

The model 500H Doppler guided proctoscope consists of two parts . The first part is a Doppler probe in a proctoscope that are used integrally with each other and are not intended to be used separately. The Doppler guided proctoscope has a removable fiber optic light pipe, and a removable 8 mHz CW Doppler probe. The second part is a combination 8 mHz continuous wave (CW) Doppler detector with loudspeaker and a light source. The Doppler guided proctoscope is inserted in the rectum and rotated until one of the branches of the hemorrhoidal artery is located. The artery is located when the user hears the classical arterial blood flow sound. The Doppler guided proctoscope is rotated such that the arterial sound is maximized thus insuring that the hemorrhoidal artery is under the Doppler probe and in the Doppler guided proctoscope's rectangular slit. The physcician or surgeon can then ligate the artery . The Doppler guided proctoscope is then rotated until the next hemorrhoidal artery branch is detected. The process is repeated until all detected hemorrhoidal arteries are located and ligated. After ligation the Doppler guided proctoscope can be rotated 360 degrees to make sure that all of the hemorrhoidal arterial branches have been ligated.