Product code SGJ— Radiology
Pulsenmore ES
- Classification name
- Ultrasound Imaging System For Acquiring Images At Home By Lay Users
- Device class
- Class 2
- Regulation
- 21 CFR 892.1590
- Advisory panel
- Radiology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code SGJ
FDA has cleared device under product code SGJ, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SGJ
Recent clearances under product code SGJ
Data sourced from openFDA. This site is unofficial and independent of the FDA.