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The ultrasound system provides imaging information, used to guide the biopsy needle through the accessory to the anatomical site where the sample of physiological material is recovered for further analysis.

The Biopsy accessory attachment and handle, function with the ESAOTE Ultrasound Transducer previously cleared via K953819, connected with the AU4 Ultrasound system cleared via K944485/S3. The biopsy accessories consist of a metal and plastic bracket and needle guides that attach to the ultrasound transducer. The AU4 system software provides for the guidance of the biopsy needle through the biopsy accessory needle guide.

The AccessPoint™ software is intended to translate different medical image formats into a single format suitable for display on a standard Personal Computer.

Generally speaking, AccessPoint is a software product designed to provide the translation of different medical image formats into a form compatible to be displayed on a standard PC. Connection between sites including hospitals, out reach clinics, physician home and office are provided through the use of e-mail. The images and reports (patient studies) may be transported via e-mail in a secure manor (encryption of data) following standards used by the Internet and local LAN (Intranet), transport systems. A description of the various elements follow: The AccessPoint™ software conforms to DICOM V3 service classes in the role of Service Class Reader.

The ARTOSCAN M is intended for diagnostic nuclear magnetic imaging of the knee, leg, ankle, foot, hand, wrist forearm and elbow. The device produces transverse, sagittal, coronal and oblique cross-sectional images displaying the internal structure of the anatomy being imaged.

ARTOSCAN M is an MRI system designed specifically to image the extremities: leg (thigh excluded), knee, ankle and foot, forearm, elbow, wrist and hand. A number of modifications have been designed to enhance the functioning of the ARTOSCAN system previously cleared under K931022. The modifications will collectively be referred to as the ARTOSCAN M. Once the modifications described herein are cleared, the ARTOSCAN M will be marketed in place of the original ARTOSCAN device. The difference in the name is very subtle and consists of adding an M after the ARTOSCAN name. Existing ARTOSCAN units (original configuration) can be upgraded to the ARTOSCAN M if the user so desires.

The Galileo Electroencephalograph with Evoked Potential option is indicated for use in the detection and display of evoked responses of electrical activity of the brain and the peripheral nervous system.

ACQ board: Analog input 32 channels, Analog output 32 channels, A/D conversion 12 bit, 10 micro sec/point, 4 converter, Accumulator 32 bit, Processor Motorola MC68000, Resident memory 1 MB, Trigger input TTL. Stimulators: a- General features: Working class I type of equipment B (acoustic and visual) I type of equipment CF (electrical), Safety requirements meets standard IEC 601-1-1 (CEI 62-5), Size 220 mm, 450 mm, 80 mm, Weight approx. 2 Kg, Power supply + 15V (0.7 A) -15V (0.7A) +5V (1A), Power absorption approx. 25 VA, Working conditions +5C/+35C; 30-75%RH, Atm pressure 700/1060 mBar, Storage and conveyance conditions -10/50C; 10-95% RH, Atm pressure 500/1060 mBar, Degree of protection against infiltration of liquids and solids IP20. b- Acoustic stimulator: Transducer Telephonics TDH39, Stimulation modes Tone, Click, Noise, Stimulation rate from 50 ms to 9980 ms (step 10 ms), Tone frequency 250,500,1000,1500,2000,2500,3000,4000,5000,7000 8000 Hz, Stimulus output Right monoaural, Left monoaural, Right monoaural + controlateral noise, Left monoaural + con- trolateral noise, binaural, Acoustic level 0,10,20,30,40,50,60,70,75,80,90 dB SL, Threshold adjustment -4,-2,0, +2, +4, +6 dB, Noise level relative to the stimulus's level -40,-30,-20,-10,0, + 10 dB, Polarity of the stimulus (in Click mode) Condensation, Rarefaction, Alternate, Duration tone mode: from 10 to 150 ms, with 10 ms steps click mode: from 50 to 960 us, 10 us steps. c- Visual stimulator: The stimulator generates two video images (pattern A and B), that are alternatively displayed on screen in response to a trigger command. Generally, each picture is composed of an arbitrary bit map of 512x256 pixels; in detail the current resident software, divides the image in 5 fields: 4 quadrants and a fixation area. Each field can contain one of the following textures: black white spatial frequency horizontal bars 1 spatial frequency horizontal bars 2 spatial frequency vertical bars 1 spatial frequency vertical bars 2 spatial frequency chequer board 1 spatial frequency chequer board 2 and the reverse of all of them. A composite video signal 1 Vpp is transmitted to the monitor with separate positive synchronisms and 8 contrast levels (2,5,10,20,30,50,75,100%) related to the maximum contrast level set on the . The line period is 64 us, the frame frequency 60 Hz. d- Electric stimulator: The electric stimulator is constant current type. Other features are: Amplitude from 0 to 50 mA, with two scales (0-5 and 0-50), Precision +/- 10% full range, Duration limited to 0.5 millisec (see Device Hazard Analysis), Isolation between the applied elements and the ground 1500 V AC (see Device Hazard Analysis), Patient's safety limited energy and stimulation frequency; protection against failure of the current sensor, Light indicators stimulus ON, overload, abnormal functioning.

The intended use is specific for each transducer: P12A - Vascular PT10A - Transcranial P10A - Cardiac PA11A - Cardiac/ Transcranial

The subject devices are diagnostic ultrasound transducers described in the following tables.

The LP13 is a diagnostic ultrasound transducer for use in laparoscopic surgery. The transducer can be used to image abdominal anatomy during laparoscopic surgical procedures. In Doppler mode, the transducer can provide information about blood flow in abdominal vessels

The LP13 is a diagnostic ultrasound transducer intended to be used in laparoscopic surgical procedures. The transducer is introduced into the abdomen through a trocar following the procedure described in the operator's manual. The distal tip of the device contains the transducer element and is movable. Movement of the transducer is controlled by the levers located on the handle of the device.

The INT13 is a diagnostic ultrasound intraoperative transducer for use in abdominal surgery. The transducer can be used to image abdominal anatomy during abdominal surgical procedures. In Doppler mode, the transducer can provide information about blood flow in abdominal vessels.

The Esaote INT13 intraoperative transducer is designed and intended to be used in open (open as opposed to laparoscopic used with a trocar) abdominal surgical procedures. More specifically, the transducer is intended to be used to image abdominal anatomy during open surgical procedures.