Product Classification

• Device: image management software for planning of otologic and neurotologic procedures
• Regulation Description: Medical image management and processing system.
• Definition: Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures.
• Physical State: software
• Technical Method: Anatomical reconstruction of the target area and geometric measurements of relevant anatomy
• Target Area: temporal bone, outer ear, middle ear, inner ear, facial nerve
• Regulation Medical Specialty: Radiology
• Review Panel: Ear Nose & Throat
• Product Code: QQE
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Dental and ENT Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 892.2050
• 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