Image Management Software For Planning Of Otologic And Neurotologic Procedures
The Image Management Software for Planning of Otologic and Neurotologic Procedures is a radiology software device intended for display, segmentation, and transfer of medical image data from medical imaging systems to support planning of otological and neurotological procedures, such as cochlear implantation or skull base surgery. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 892.2050 in the Radiology specialty (reviewed by the Ear, Nose, Throat panel). It carries product code QQE and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QQE
- Device Class
- FDA class 2
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
Definition
Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.