The following data is part of a premarket notification filed by Surgical Information Sciences, Inc. with the FDA for Sis Software Version 3.6.0.
| Device ID | K192304 |
| 510k Number | K192304 |
| Device Name: | SIS Software Version 3.6.0 |
| Classification | System, Image Processing, Radiological |
| Applicant | Surgical Information Sciences, Inc. 10405 6th Avenue North, Suite 110 Plymouth, MN 55441 |
| Contact | Ann Quinlan-smith |
| Correspondent | Kelliann Payne Hogan Lovells, US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-23 |
| Decision Date | 2019-09-13 |
| Summary: | summary |