LymphaTech Mobile 3D Measuring Tool

The LymphaTech Mobile 3D Measuring Tool is a software application that uses a long-wave infrared camera (Structure Sensor) attached to an iPad to capture 3D models of body regions and measure their diameter, surface area, volume, and circumference. It is intended as a non-contact adjunctive measurement tool for trained healthcare professionals to record body part data in clinical settings for non-pregnant adults, without providing diagnosis or therapy.

The subject device is software-only that processes input from an off-the-shelf long-wave infrared camera and iPad (iOS 14+), storing measurements locally on the device. The predicate Scout is a hardware combination device integrating digital and thermal cameras with cloud connectivity and EMR integration. Both measure physical dimensions non-contactively, but the subject device uniquely measures volume and lacks the thermal/temperature measurement and connectivity features of the predicate.

Not stated in this summary. The document lists testing types (Software Verification Testing, Cybersecurity Testing, Usability Testing, Non-Clinical Bench Performance Testing) but does not cite specific consensus standards such as ISO, IEC, or ASTM.

Both devices are Class I surgical cameras used for non-contact measurement of body part dimensions in clinical settings by trained clinicians on non-pregnant adults without providing diagnosis or therapy. They share the same regulatory classification (21 CFR 878.4160) and product code family, similar intended use for physical measurements, and identical bench and usability testing approaches. Although the subject device differs in using software-only processing with an iPad and measuring volume rather than temperature, these differences do not raise different questions of safety or effectiveness because they represent predictable technological variations performing the same fundamental measurement function.