| Device |
ultrasound imaging system for acquiring images at home by lay users |
| Definition |
An ultrasound imaging system for acquiring images at home by lay users is a prescription home use device that may consist of hardware and/or software intended for acquiring ultrasound images for interpretation by a qualified health care professional (e.g., fetal images for determination of fetal heart rate). The device provides guidance to lay users to aid image acquisition. |
| Physical State |
Hardware and/or software for acquiring, processing and displaying ultrasound images |
| Technical Method |
The ultrasound images are acquired in home environment by the lay users using guidance provided by the device software or under direct supervision of a qualified healthcare professional. |
| Target Area |
Human body |
| Regulation Medical Specialty |
Radiology |
| Review Panel |
Radiology |
|---|
| Product Code | SGJ |
|---|
| Premarket Review |
Office of Radiological Health
(OHT8)
Radiological Imaging and Radiation Therapy Devices
(DHT8C)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
892.1590
|
|---|
| 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 |
