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New device: The BladderMass™ BVM 6500 is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume and bladder wall mass noninvasively. The BladderMass BVM 6500 is contraindicated for fetal use and for use on pregnant patients.

The Diagnostic Ultrasound BladderMass BVMTM 6500 Ultrasound System is a hand-held, battery powered, software controlled ultrasound system used to acquire and display real time B-mode images of the bladder. The system is intended to non invasively monitor bladder volume on an intermittent basis. The system is an effective, low cost, simple option for use in a clinical hospital or nursing home setting or for home use under medical supervision.

The intended uses of the BVI 6100 System, as defined by FDA quidance documents, is for Abdominal (Adult and Pediatric) applications. The BVI 6100 System is intended to project ultrasound energy through the lower abdomen of a nonpregnant patient to obtain an image of the bladder and measure urinary bladder volume non-invasively on an intermittent basis. The indications for use are the same as for Diagnostic Ultrasound's predicate devices. The BladderScan BVI 6100 is contraindicated for fetal use and for use on pregnant patients.

The BladderScan™ BVI 6100 Ultrasound System is a hand-held, batterypowered, software-controlled ultrasound system used to acquire and display real-time B-mode images of the bladder. The System is intended to non-invasively monitor bladder volume on an intermittent basis. The System is an effective, low cost, simple option for use in a clinical hospital or nursing home setting or for home use under medical supervision.

The BladderManager® PC1 5000(+) is intended to project ultrasound energy through r he bladenwanager of the non-pregnant in order to obtain an image of the bladder that is used to determine bladder volume non-invasively. This capability is provided in 2 fundamental modes; 1) hand held probe, aimed by user to obtain reading and 2) Automatically monitor bladder volume via a garment-held probe on non-mobile, supine patient. Patients and/or caregivers are alerted visually and/or audibly when the bladder volume exceeds a pre-programmed threshold.

The BladderManager PCI 5000 is a portable, battery powered ultrasound instrument designed for a patient to non-invasively monitor his or her bladder volume on an intermittent basis.

The BladderManager PCI 5000 and BladderScan BVI 5000 "project ultrasound energy through the lower abdomen of the non-pregnant patient to obtain an image of the bladder that is used to determine bladder volume non-invasively." This statement of intended use is unchanged with the DxU Gel Pad.

The BladderManager PCI 5000 is a portable, battery-powered ultrasound instrument designed for a patient to non-invasively monitor his or her bladder volume on an intermittent basis. The BladderScan BVI 5000 is similar, except that it is designed for use by the clinician with the added feature of a "docking cradle" containing an onboard computer that provides a hard copy printout of the scan images and the bladder volume. For both instruments, the scanhead is applied to the patient's abdomen with a hydrogel pad providing ultrasound transmission coupling between the scanhead and the patient's body. Standard ultrasound gel can also be used by itself or in addition to the hydrogel pad, depending on patient preference. The hydrogel pad used in the original 510(k) submission, the Koolgel gel pad, is composed of water and polyethylene oxide, manufactured with the identical formulation as a previously cleared device (Ad-Heal wound dressing, K881731). The object of this submission, the DxU Gel Pad, is composed of distilled water, glycerol, gracillaria agar, carrageenan, methyl paraben, and propyl paraben.

The BladderManager PCI 5000 and BladderScan BVI 5000 "project ultrasound energy through the lower abdomen of the non-pregnant patient to obtain an image of the bladder that is used to determine bladder volume non-invasively."

The BladderManager PCI 5000 is a portable, battery-powered ultrasound instrument designed for a patient to non-invasively monitor his or her bladder volume on an intermittent basis. The BladderScan BVI 5000 is similar, except that it is designed for use by the clinician with the added feature of a "docking cradle" containing an onboard computer that provides a hard copy printout of the scan images and the bladder volume.

The BladderManager PCI 5000 and BladderScan BVI 5000 "project ultrasound energy through the lower abdomen of the non-pregnant patient to obtain an image of the bladder that is used to determine bladder volume non-invasively."

The BladderManager PCI 5000 is a portable, battery-powered ultrasound instrument designed for a patient to non-invasively monitor his or her bladder volume on an intermittent basis. The BladderScan BVI 5000 is similar, except that it is designed for use by the clinician with the added feature of a "docking cradle" containing an onboard computer that provides a hard copy printout of the scan images and the bladder volume.