MOSkin Radiation Measurement System

The MOSkin Radiation Measurement System is a dosimeter that measures radiation dose delivered to a patient during radiotherapy and diagnostic imaging procedures. It consists of a MOSFET-based radiation dosimeter (RD) sensor, a reading device (HUB), and software for dose calculation and reporting. The system is intended for verification of radiation-producing device output and does not directly adjust patient dose.

Both the MOSkin and predicate device use MOSFET (metal-oxide-semiconductor field-effect transistor) technology and measure dose via threshold voltage change proportional to radiation exposure. MOSkin improvements include: doubled dose range (up to 400 cGy vs. 200 cGy), single-use dosimeters eliminating sterilization needs, smaller dosimeter package (54 mm³ vs. 150 mm³), wireless connectivity, and tablet-based interface versus desktop computer.

ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation); IEC 60601-1 and related standards (electrical safety and EMC); ISTA 3A (environmental transport); 47 CFR Part 15 (radio frequency); ETSI EN 300 328 (2.4 GHz ISM band); IEC 60601-1-6 (usability); FDA software guidance documentation.

Both devices provide dosimetry and verification of radiation-producing device output using identical MOSFET measurement technology and threshold voltage principles. Although MOSkin has enhanced features (wider dose range, wireless, smaller size, tablet interface), these differences do not raise new or different questions of safety or effectiveness. All performance testing, usability studies, mechanical testing, and clinical requirements demonstrated equivalence to the predicate device K092285.