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510(k) Data Aggregation
K Number
K121689Device Name
VITASCAN LT SCANMASTER
Manufacturer
Date Cleared
2012-09-19
(104 days)
Product Code
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
VITACON MEDICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VitaScan LT (aka. Scanmaster) is a B-mode ultrasonic instrument which projects ultrasound energy through the lower abdomen of the non-pregnant patient to obtain an image of the bladder which is used to determine bladder volume non-invasively, on an intermittent basis. Bladder scanning measures ultrasonic reflections within a patient's body and differentiates the urinary bladder from the surrounding tissues. The intended use of the device, as defined by FDA guidance documents, is for Abdominal (adult and pediatric) applications.
VitaScan LT is applicable in many clinical areas to determine bladder volume, time for bladder emptying and detection of post void residual volume (PVR).
Device Description
The VitaScan LT (aka. Scanmaster) is a hand held, B mode ultrasound scanner with a USB interface to a personal computer. This software controlled ultrasound system is used to acquire and display representations of the bladder, from which the bladder volume can be calculated. The system is intended to non-invasively monitor bladder volume on an intermittent basis which may be used to assist in the determination of time for bladder emptying and for the detection of post void residual volume (PVR).
The VitaScan LT (aka. Scanmaster) is a Track 1 System and meets the FDA's preammendment acoustic output limits for "fetal imaging and other" applications.
The VitaScan LT (aka. Scanmaster) is a 2.3 MHz mechanical sector scanner which operates only in the B mode to locate the bladder and automatically calculate the bladder volume. The ultrasonic power transmitted by the system is not user adjustable. Bladder Volume, Patient ID, Patient Name, Gender, Age and Hospital Name are displayed and stored on the personal computer application program provided with the VitaScan LT (aka. Scanmaster), which is connected to, and receives power through, the USB port of the personal computer.
VitaScan LT (aka. Scanmaster) is applied to the patient's abdomen, immediately superior to the patient's symphysis pubis with an ultrasound gel interface. The transducer collects cross-sectional images of the bladder from up to 24 scan planes and transmits the image information to the personal computer via the USB connection. Using this information, the VitaScan LT application program constructs a finite element model of the bladder and automatically computers the volume of the bladder via volumetric integration.
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