Last synced on 19 July 2024 at 11:05 pm

Diagnostic Ultrasonic Transducer, Robotic

Page Type
Product Code
Definition
Diagnostic ultrasonic imaging or monitoring.
Physical State
piezoelectric material
Technical Method
Robotic component maintains signal and recovers lost signal.
Target Area
Unspecified
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.1570
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 892.1570 Diagnostic ultrasonic transducer

§ 892.1570 Diagnostic ultrasonic transducer.

(a) Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

(b) Classification. Class II.

Diagnostic Ultrasonic Transducer, Robotic

Page Type
Product Code
Definition
Diagnostic ultrasonic imaging or monitoring.
Physical State
piezoelectric material
Technical Method
Robotic component maintains signal and recovers lost signal.
Target Area
Unspecified
Regulation Medical Specialty
Radiology
Review Panel
Radiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
892.1570
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 892.1570 Diagnostic ultrasonic transducer

§ 892.1570 Diagnostic ultrasonic transducer.

(a) Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

(b) Classification. Class II.