QQE — Image Management Software For Planning Of Otologic And Neurotologic Procedures Class II
FDA product code QQE covers "Image Management Software For Planning Of Otologic And Neurotologic Procedures", a Class II medical device regulated under 21 CFR 892.2050. Submissions are reviewed by the Radiology panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QQE
- Device Class
- Class II
- Regulation Number
- 892.2050
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Radiology
- Implant
- No
Definition
Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures.