MDR-01-01

Patient-specific vascular planning model

نموذج تخطيطي وعائي خاص بالمريض

Offered in year 1

Open the door. Invoice services and non-device models. No EDA device file yet.

A rigid or silicone model from the patient’s CTA or MRA, with a written deviation note against the source imaging.

• 

  A demonstration segmentation, not a Smouha patient. The coronaries, sinuses of Valsalva, leaflets, aorta, ventricles, atrium and myocardium are separated before anyone prints a model. That is how a clinician sees the anatomy, checks whether a device can fit, and meets the difficult part of the case before the operating room.

Regulatory posture

Not a medical device. For planning, rehearsal or training. Not for diagnosis or implantation.

Who it is for

Surgeons and interventionalists at Smouha

Kind

Planning model

Limit

Rejected if source slices are thicker than 0.75 mm or consent is missing.

What is in the line

• De-identified mesh
• Printed or cast model
• Segmentation deviation note