FDA product code SGJ: Ultrasound Imaging System For Acquiring Images At Home By Lay Users
SGJ is the FDA product code for ultrasound imaging system for acquiring images at home by lay users. It is a Class II device, regulated under 21 CFR 892.1590 and reviewed by the Radiology panel. Devices under SGJ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Ultrasound Imaging System For Acquiring Images At Home By Lay Users |
| Device class | Class II |
| Regulation | 21 CFR 892.1590 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
Recalls for SGJ devices
openFDA lists no recalls for product code SGJ.
Frequently asked questions
What is FDA product code SGJ?
SGJ is the FDA product code for ultrasound imaging system for acquiring images at home by lay users. It is a Class II device, regulated under 21 CFR 892.1590 and reviewed by the Radiology panel.
What device class is SGJ?
Class II, regulation 21 CFR 892.1590. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SGJ
- Run a recall and safety report across every SGJ manufacturer
- Watch product code SGJ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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