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U.S. Department of Health and Human Services

Product Classification

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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 CodeQJG
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
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
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