The following data is part of a premarket notification filed by Inteware Co., Ltd. with the FDA for Orthoanalysis Software.
| Device ID | K183695 |
| 510k Number | K183695 |
| Device Name: | OrthoAnalysis Software |
| Classification | Orthodontic Software |
| Applicant | Inteware Co., Ltd. 4F., No.93, Xinzheng 5th St., Taiwan, R.O.C. Minxiong Township, Chiayi Country 62145, CN 621 |
| Contact | Wayne Tsai |
| Correspondent | Wayne Tsai Inteware Co., Ltd. 4F., No.93, Xinzheng 5th St., Taiwan, R.O.C. Minxiong Township, Chiayi Country 62145, CN 621 |
| Product Code | PNN |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-31 |
| Decision Date | 2019-09-12 |