K173965 is an FDA 510(k) clearance for the Implant Planning Software. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Inteware Co., Ltd. (Minxiong Township, Chiayi Country, CN). The FDA issued a Cleared decision on October 26, 2018, 301 days after receiving the submission on December 29, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K173965 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 2017 |
| Decision Date | October 26, 2018 |
| Days to Decision | 301 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |