B-Scan

The B-Scan is an ultrasound imaging device that uses pulsed echo technology to visualize the internal structure of the eye, including opaque media and posterior pathology. It is intended for diagnosing pathological or traumatic eye conditions in both adult and pediatric patients and is used by trained ophthalmic professionals.

The subject device has a hyperbolic paraboloid membrane profile (vs. flat), operates at 12 MHz nominal frequency, achieves 60 mm depth penetration with fixed gain (0-112 dB) and fixed frequency, supports USB 2 and 3 connectivity, and uses transducer calibration stored in EEPROM at the scan head. Minor differences include increased sampling rate (4096 vs. 2048 points per line), slightly different frame rates, and enhanced cybersecurity in the user interface, while core clinical algorithms remain identical to the predicate.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-37 (ultrasound devices), ISO 10993 series (biocompatibility testing including cytotoxicity, ocular irritation, and skin sensitization). Bench testing included accelerated thermal cycling, UV assessment, transit performance, USB pull testing, and repeated reprocessing validation.

The subject device has identical indications for use, intended user profile, and clinical purpose as the predicate B-Scan Plus. Although technological characteristics differ (membrane profile, interface enhancements, transducer calibration storage location), these differences do not raise new safety or effectiveness questions because all critical clinical functions use the same algorithms, the device operates in the same clinical environment, biocompatibility and performance testing meet or exceed predicate specifications, and the subject device demonstrates equivalent or superior safety and effectiveness to the predicate device.