FDA product code SHE: Radiological Software System For Delivery Date Prediction
SHE is the FDA product code for radiological software system for delivery date prediction. It is a Class II device, regulated under 21 CFR 892.8200 and reviewed by the Radiology panel. Devices under SHE reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
Definition
A radiological software system for delivery date prediction is a software-only device that analyzes obstetric radiological images to predict the delivery date of a pregnancy. The device output does not replace a clinician's review or judgment on the progression of a pregnancy and should be used in conjunction with other clinical and diagnostic findings. The device does not identify at-risk pregnancies or identify specific complications.
Classification
| Field | Value |
|---|---|
| Device name | Radiological Software System For Delivery Date Prediction |
| Device class | Class II |
| Regulation | 21 CFR 892.8200 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) |
Recalls for SHE devices
openFDA lists no recalls for product code SHE.
Frequently asked questions
What is FDA product code SHE?
SHE is the FDA product code for radiological software system for delivery date prediction. It is a Class II device, regulated under 21 CFR 892.8200 and reviewed by the Radiology panel.
What device class is SHE?
Class II, regulation 21 CFR 892.8200. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SHE
- Run a recall and safety report across every SHE manufacturer
- Watch product code SHE 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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