SIS Software version 3.3.0
by Surgical Information Sciences, Inc.
510(k) K183019
SIS Software version 3.3.0 is a Class II device made by Surgical Information Sciences, Inc., cleared under FDA 510(k) K183019 on 19 Mar 2019, 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 | NumberK183019 | Date19 Mar 2019 | StatusActive |
Official records
- FDA 510(k) database K183019
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- Withdrawn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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