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Medical Device Classification - Laser Guided Positioner

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  Post Number #1  
Old 15th July 2017, 09:30 AM

Total Posts: 38
Please Help! Medical Device Classification - Laser Guided Positioner

Dear Friends and Forum colleagues,

I am kind of confused in classifying a product. Request your help. The Intended use of the product is something like this "This is an optical guidance system that intends to guide positioning and aligning of Needle for biopsy by traditional free-hand technique. The unit uses CT images to identify the location and angle of needle entry"

The product does not provide any robotic or guidance arm to position the needle. It simply provides the laser light and the clinician needs to insert the needle at the laser point on the body at the angle of laser light in such a way that there is no shadow of the needle is made indicating the angle of entry.

I would like to know under MDD classifiction which rule will apply to this product?


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  Post Number #2  
Old 17th July 2017, 03:40 AM

Total Posts: 5
Re: Medical Device Classification - Laser Guided Positioner

To me it sounds like this could fall under rule 12 as class I.
Thanks to Turquoise202 for your informative Post and/or Attachment!
  Post Number #3  
Old 17th July 2017, 05:49 AM

Total Posts: 38
Re: Medical Device Classification - Laser Guided Positioner

Thank you Torquise for your reply. But a similar product called SimpliCT is classified as IIa but not sure under which rule. Also I am unable to decide if it will come under Active Therapeutic?

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