SHEClass II
Radiological Software System For Delivery Date Prediction
Radiology · 21 CFR 892.8200
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.
MDR events0All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances1All time
Recent MDR events
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Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
1 clearances for this product code