SIS Software Version 3.6.0
by Surgical Information Sciences, Inc.
510(k) K192304
SIS Software Version 3.6.0 is a Class II device made by Surgical Information Sciences, Inc., cleared under FDA 510(k) K192304 on 13 Sep 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 | NumberK192304 | Date13 Sep 2019 | StatusActive |
Official records
- FDA 510(k) database K192304
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- Withdrawn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
Similar devices
Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).
- CORONIS 5MP by Barco N.V.
- SURGERY REHEARSAL PLATFORM by SURGICAL THEATER LLC
- AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE by Karl Storz Endoscopy-America, Inc.
- Minimally Invasive Prostate Surgery Navigation System by Augment Intelligent Medical System (China) Co., Ltd.
- RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0 by Calgary Scientific, Inc.
- SubtleMR (2.3.x) by Subtle Medical, Inc.
- Synapse 3D, Synapse 3D Base Tools v6.1 by FUJIFILM CORPORATION
- 3D-Anywhere by Provect.AI
- MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO) by Medecom Sarl
- JiveX by Visus Technology Transfer GmbH