SpectoMed (v1.0)

SpectoMed (v1.0) is a software-only medical imaging device that processes CT and MRI data into 3D, virtual reality, and augmented reality visualizations. It enables healthcare professionals to review, manipulate, measure, and analyze multi-dimensional medical images for preoperative surgical planning and intraoperative display in hospitals and clinical settings.

Both the subject device and predicate device (Avatar Medical Software V1) are Class II medical image management and processing systems with identical product codes (LLZ) and regulatory numbers (21 CFR 892.2050). Both support interactive manipulation, filtering, annotations, measurements, and image panning. The key difference is that SpectoMed does not include remote streaming capability, which the applicant states does not impact safety or efficacy.

ANSI AAMI IEC 62304:2006/A1:2016 (Medical device software – Software life cycle processes); FDA guidance documents 'Guidance for the Content of Premarket Submissions for Device Software Functions' and 'Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.' Measurement performance was validated against Osirix MD (K101342), a cleared reference device.

The subject and predicate devices share identical indications for use (CT/MR viewing and surgical planning), regulatory classification, product code, and core technological features including image analysis, measurements, and panning. Measurement performance testing demonstrated no statistically significant difference between SpectoMed and the reference device Osirix MD using t-test statistics across varying CT phantom resolutions. The omission of remote streaming does not affect safety or effectiveness, as both devices serve the same preoperative and intraoperative functions using equivalent technologies.