SGJ · Class II · 21 CFR 892.1590

FDA Product Code SGJ: Ultrasound Imaging System For Acquiring Images At Home By Lay Users

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.

Leading manufacturers include Pulsenmore, Ltd..

1
Total
0
Cleared
324d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Ultrasound Imaging System For Acquiring Images At Home By Lay Users Devices (Product Code SGJ)

1 devices
1–1 of 1
Not Cleared Oct 31, 2025
Pulsenmore ES
DEN240074
Pulsenmore, Ltd.
Radiology · 324d

About Product Code SGJ - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SGJ since 2025, with 0 receiving FDA clearance (average review time: 324 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SGJ devices are reviewed by the Radiology panel. Browse all Radiology devices →