SGJ — Ultrasound Imaging System For Acquiring Images At Home By Lay Users Class II
FDA product code SGJ covers "Ultrasound Imaging System For Acquiring Images At Home By Lay Users", a Class II medical device regulated under 21 CFR 892.1590. Submissions are reviewed by the Radiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SGJ
- Device Class
- Class II
- Regulation Number
- 892.1590
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240074 | Pulsenmore | Pulsenmore ES | Oct 31, 2025 |