Device |
diagnostic ultrasonic transducer, robotic |
Regulation Description |
Diagnostic ultrasonic transducer. |
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 |
Product Code | OQQ |
Premarket Review |
Office of Radiological Health
(OHT8)
Radiological Imaging and Radiation Therapy Devices
(DHT8C)
|
Submission Type |
510(k)
|
Regulation Number |
892.1570
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Recognized Consensus Standard
|
Third Party Review
|
Accredited Persons
|