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510(k) Data Aggregation
K Number
K070907Device Name
INTERSON USB ULTRASOUND PROBE SYSTEM
Manufacturer
REGULATORY MANAGEMENT SERVICES
Date Cleared
2007-04-17
(15 days)
Product Code
IYO
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
REGULATORY MANAGEMENT SERVICES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Opthalmic, Fetal, Abdominal, Intra-Operative (Specify), Intra-Operative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Trans-Rectal, Trans-Vaginal, Trans-Urethral, Intra-Vascular, Peripheral -Vascular, Laparascopic, Muscular-Skeletal Conventional, Muscular-Skeletal Superficial, Others (Specify)
Mode of Operation: A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Color Velocity Imaging, Combined (B - M), Other (Specify)
Note 1: Abdominal, Solid organs, aneurysms,
Note 2: Small Organ: breast, thyroid, testes.
Note 3: Includes imaging for guidance of biopsy
Device Description
The Interson USB Ultrasound Probe System is a self contained portable, multiple-mode, and multiple-application ultrasound imaging system. The system contains an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface and control offering a full complement of conventional operating modes, software-based parameter controls, and recording. The selection eight transducers to be offered with the system permits a wide range of clinical applications including fetal heart, abdomen, OB/GYN, vascular, extremity, pediatric, cardiac, neonatal cephalic, urology, ophthalmology. With these general areas of intended use, the various transducers adapt the system for the specific imaging tasks. Eight different models of the USB Ultrasound Probe System are available and any two may be connected at the same time to a USB 2.0 port. In addition to the initial operational settings for each USB Ultrasound Probe System are preprogrammed in the system. User-customized parameter settings for each USB Ultrasound Probe System may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the cine function. The Interson USB Ultrasound Probe System is a B-Mode scanner and supports a wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance. Probes are supported in frequencies from 2.5 MHz to 12.0 MHz. These probes can be applied to a variety of fields such as fetal heart, abdomen, OB/GYN, vascular, extremity, pediatric, neonatal cephalic, cardiac, ophthalmology, and urology. The Interson USB Ultrasound Probe System provides various measuring functions. It can measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipito-frontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APTD (anteroposterior trunk diameter), TTD (transverse trunk diameter), GS (gestational sac), and LMP (last menstral period). Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of Interson USB Ultrasound Probe System is B-Mode, The Interson USB Ultrasound Probe System supports the Cine function (capable of storing up to 32 to 512 sequential images). Management of patient history is possible by image-storage function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.
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