The following data is part of a premarket notification filed by Inteware Co. Ltd. with the FDA for Implant Planning Software.
| Device ID | K173965 |
| 510k Number | K173965 |
| Device Name: | Implant Planning Software |
| Classification | System, Image Processing, Radiological |
| Applicant | Inteware Co. Ltd. 4F., No.93, Xinzheng 5th St. Minxiong Township, Chiayi Country, CN 62145 |
| Contact | Wayne Tsai |
| Correspondent | Wayne Tsai Inteware Co. Ltd. 4F., No.93, Xinzheng 5th St. Minxiong Township, Chiayi Country, CN 62145 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-29 |
| Decision Date | 2018-10-26 |