Palm Bladder Scanner PBSV5.1

The Palm Bladder Scanner - PBSV5.1 is designed for non-invasive bladder volume measurement, particularly to assess residual urine volume in real-time. Clinicians use it to evaluate urinary retention or monitor bladder function, helping to diagnose or manage conditions where accurate bladder volume assessment is critical, such as post-micturition residual checks or in patients with neurogenic bladder issues.

The device is designed for both single-use and reusable applications, depending on clinical workflows and infection control protocols. If reusable, it must be cleaned, disinfected, and maintained according to the manufacturer’s guidelines to ensure accuracy and functionality. Sterility is specified as an option, so facilities should confirm whether their unit is supplied sterile or non-sterile to align with their reprocessing policies.

The device must be stored and handled per the manufacturer’s instructions to preserve its performance. Since it operates in ultrasound-compatible environments, it should be kept away from sources of electromagnetic interference. If reusable, it should be stored in a clean, dry location with protective packaging to prevent damage, and any sterilization (if applicable) should follow validated protocols to avoid compromising its technical specifications.

The device holds FDA 510(k) clearance under Special Review and complies with the Medical Device Directive (MDD). This means it has undergone rigorous evaluation by the FDA’s Radiology Advisory Committee (RA) to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and performance standards for clinical use in the U.S. and EU markets. The classification under product code IYO (ultrasound systems) further confirms its regulatory alignment with non-invasive imaging devices.