The following data is part of a premarket notification filed by Surgical Information Sciences, Inc. with the FDA for Sis System (version 5.1.0).
| Device ID | K210071 |
| 510k Number | K210071 |
| Device Name: | SIS System (Version 5.1.0) |
| Classification | System, Image Processing, Radiological |
| Applicant | Surgical Information Sciences, Inc. 10405 6th Avenue N, Suite 110 Plymouth, MN 55441 |
| Contact | Ann Quinlan-smith |
| Correspondent | Kelliann H. Payne Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, PA 19103 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-11 |
| Decision Date | 2021-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001580907 | K210071 | 000 |