SIS Software
by Surgical Information Sciences, Inc.
510(k) K162830
SIS Software is a Class II device made by Surgical Information Sciences, Inc., cleared under FDA 510(k) K162830 on 14 Feb 2017, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162830 | Date14 Feb 2017 | StatusActive |
Official records
- FDA 510(k) database K162830
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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