Diagnostic Low Electric Field
The Diagnostic Low Electric Field Device (product code OEE) is a surgical adjunctive tool used to guide the shaving of tissue at the tumor margins during excisional breast surgery, assisting surgeons in locating tissue for excision alongside standard intraoperative imaging and palpation techniques. It uses low-level electric field sensing to differentiate between cancerous and normal tissue at surgical margins. This device is FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) given the critical oncological application; it has no assigned regulation number or medical specialty code. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OEE
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- SU
- Submission Type
- 2
Device Characteristics
Definition
As an adjunctive tool to guide the shavings of tissue at the margins of the tumor for use in excisional breast surgery to assist in locating the tissue for excision. In addition to other standard methods such as intraoperative imaging and palpation.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.