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Device System, Imaging, Tympanic Membrane And Middle Ear

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.1560
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1560 Ultrasonic pulsed echo imaging system

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a) Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]

Device System, Imaging, Tympanic Membrane And Middle Ear

Page Type
Product Code
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
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.1560
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1560 Ultrasonic pulsed echo imaging system

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a) Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019]