DEN240074 is an FDA 510(k) submission for the Pulsenmore ES. This device is classified as a Ultrasound Imaging System For Acquiring Images At Home By Lay Users (Class II - Special Controls, product code SGJ).
Submitted by Pulsenmore, Ltd. (Omer, IL). The FDA issued a Not Cleared (DENG) decision on October 31, 2025.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1590. 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..
| 510(k) Number | DEN240074 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 11, 2024 |
| Decision Date | October 31, 2025 |
| Days to Decision | 324 days |
| Submission Type | Direct |
| Review Panel | Radiology (RA) |
| Summary | - |
| Product Code | SGJ - Ultrasound Imaging System For Acquiring Images At Home By Lay Users |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1590 |
| 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. |