Product Classification

• Device: endoscopic video imaging system / software component for real time video augmentation
• Regulation Description: Endoscope and accessories.
• Definition: To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor.
• Physical State: software algorithm
• Technical Method: Software that uses artificial intelligence/machine learning (AI/ML) advanced algorithms to that is used to augment video images
• Target Area: various body cavities, hollow organs, and canals
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: General & Plastic Surgery
• Product Code: SFE
• Premarket Review: General Surgery Devices (DHT4A); General Surgery Devices (DHT4A)
• Submission Type: 510(k)
• Regulation Number: 876.1500
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible