Last synced on 2 December 2022 at 11:04 pm

Ultrasound Bronchoscope

Page Type
Product Code
Definition
An ultrasound bronchoscope is indicated for the ultrasonic visualization, diagnosis and therapeutic access to the bronchial tree or the lungs. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Physical State
ultrasound bronchoscope
Technical Method
An ultrasound bronchoscope has a built-in ultrasound transducer (probe) at the distal end. When used with an ultrasound processor the ultrasound bronchoscope produces ultrasound wave and scans the signals reflected by tissues to generate the ultrasound image.
Target Area
bronchial tree and lungs
Regulation Medical Specialty
Radiology
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.1550
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1550 Ultrasonic pulsed doppler imaging system

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a) Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.

Ultrasound Bronchoscope

Page Type
Product Code
Definition
An ultrasound bronchoscope is indicated for the ultrasonic visualization, diagnosis and therapeutic access to the bronchial tree or the lungs. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Physical State
ultrasound bronchoscope
Technical Method
An ultrasound bronchoscope has a built-in ultrasound transducer (probe) at the distal end. When used with an ultrasound processor the ultrasound bronchoscope produces ultrasound wave and scans the signals reflected by tissues to generate the ultrasound image.
Target Area
bronchial tree and lungs
Regulation Medical Specialty
Radiology
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.1550
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 892.1550 Ultrasonic pulsed doppler imaging system

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a) Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II.