The following data is part of a premarket notification filed by Corin Usa with the FDA for Optimized Positioning System (ops) Insight.
| Device ID | K192656 |
| 510k Number | K192656 |
| Device Name: | Optimized Positioning System (OPS) Insight |
| Classification | System, Image Processing, Radiological |
| Applicant | Corin USA 12750 Citrus Park Lane, Suite 120 Tampa, FL 33625 |
| Contact | Lucinda Gerber |
| Correspondent | Crissy Tomarelli Corin (Australia) 17 Bridge Street Sydney, AU 2073 |
| Product Code | LLZ |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| Subsequent Product Code | PLW |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-25 |
| Decision Date | 2020-05-01 |