Device |
image management software for planning of otologic and neurotologic procedures |
Regulation Description |
Medical image management and processing system. |
Definition |
Display, segmentation, and transfer of medical image data from medical imaging systems for planning of otological and neurotological procedures. |
Physical State |
software |
Technical Method |
Anatomical reconstruction of the target area and geometric measurements of relevant anatomy |
Target Area |
temporal bone, outer ear, middle ear, inner ear, facial nerve |
Regulation Medical Specialty |
Radiology |
Review Panel |
Ear Nose & Throat |
Product Code | QQE |
Premarket Review |
Division of Dental and ENT Devices
(DHT1B)
Division of Dental and ENT Devices
(DHT1B)
|
Submission Type |
510(k)
|
Regulation Number |
892.2050
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |