Product Classification

• Device: device system, imaging, tympanic membrane and middle ear
• Regulation Description: Ultrasonic pulsed echo imaging system.
• Definition: Is intended for use as an imaging tool for visualization of the human tympanic membrane and middle ear space.
• Physical State: This device includes an optical coherence tomography (OCT) broadband light source, OCT optical module, software, imaging acquisition system, imaging handheld probe, and monitor.
• Technical Method: This device uses video otoscopy and optical coherence tomography to visualize the tympanic membrane and middle ear space.
• Target Area: Outer and Middle Ear
• Regulation Medical Specialty: Radiology
• Review Panel: Ear Nose & Throat
• Product Code: QJG
• 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: 892.1560
• 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