The following data is part of a premarket notification filed by Surgical Information Sciences, Inc. with the FDA for Sis Software.
| Device ID | K162830 |
| 510k Number | K162830 |
| Device Name: | SIS Software |
| Classification | System, Image Processing, Radiological |
| Applicant | Surgical Information Sciences, Inc. 60 South 6th Street, Suite 2410 Minneapolis, MN 55402 |
| Contact | Mark Headrick |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103 |
| Product Code | LLZ |
| Subsequent Product Code | HAW |
| Subsequent Product Code | LNH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-07 |
| Decision Date | 2017-02-14 |
| Summary: | summary |