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Image Management Software For Planning Of Otologic And Neurotologic Procedures

FDA product code QQE · 3 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.2050
Review panel
EN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2021-08-20 – 2025-04-11

Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures.

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