SOTA Cloud Smart Sensor (1.5)

The SOTA Cloud Smart Sensor (1.5) is a USB-powered digital intraoral X-ray detector for use in dental practices. It converts X-ray photons to visible light via a cesium iodide scintillator, then transmits the resulting digital images through a fiber optic plate to a CMOS detector for display and archiving by trained dental professionals.

The subject device uses an indirect CsI-on-CMOS architecture with 18.5 µm pixel pitch, 1296 × 1772 pixel resolution, and measured spatial resolution of 14.3 lp/mm. The predicate uses a direct semiconductor architecture with 70 µm pixel pitch and 344 × 417 pixel resolution at 7 lp/mm. Despite these differences, both achieve comparable modulation transfer function performance at clinically relevant spatial frequencies and identical low-contrast resolution.

Electrical safety and electromagnetic compatibility evaluated per IEC 60601-1 and IEC 60601-1-2. Bench testing assessed spatial resolution, image uniformity, and low-contrast performance. Clinical evaluation used structured criteria addressing image quality, spatial resolution, contrast, uniformity, artifact presence, and suitability for dental diagnostic tasks.

The SOTA Cloud Smart Sensor has the same intended use, fundamental operating principles, and clinical workflow as the predicate Digital Intraoral X-Ray Sensor (K220277). Non-clinical bench testing demonstrates comparable spatial resolution and contrast performance at clinically relevant frequencies, and clinical evaluation confirms diagnostically acceptable images suitable for common dental tasks. The technological differences do not raise new questions of safety or effectiveness.