SNN Fluoro Navigation System
FDA 510(k) K993673 · I.S.G. Technologies, Inc.
510(k) numberK993673
Submission
- Device name
- SNN Fluoro Navigation System
- Applicant
- I.S.G. Technologies, Inc.
Mississauga Ontario, CA - Received
- November 1, 1999
- Decision date
- December 21, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HAW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional | Koh Young Technology, Inc. | 09/10/2026SE |
| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | Elekta Solutions AB | 08/05/2026SE |
| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
| K253379 | Stealth AXiS Cranial clinical applicationHAW · Traditional | Medtronic Navigation, Inc. | 03/26/2026SE |
| K231897 | NeuroAlign softwareHAW · Traditional | Medivis, Inc. | 10/21/2025SE |
| K251317 | SOLOPASS 2.0 SystemHAW · Traditional | Intravent Medical Partners | 09/05/2025SE |
| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | Bayer Medical Care, Inc. | 09/04/2025SE |
| K250505 | Ez-FiducialsHAW · Traditional | Phasor Health, LLC | 07/09/2025SE |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional | Brain Navi Biotechnology Co., Ltd. | 05/23/2025SE |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional | Claronav | 02/05/2025SE |
More from Claronav
| 510(k) | Device | Decision |
|---|---|---|
| K982570 | SNN ScoutHAW · Traditional | 01/13/1999SE |
| K980684 | VR NetserveLMD · Traditional | 05/06/1998SE |
| K973413 | Id. Store (Release 2.0)LMB · Traditional | 11/25/1997SE |
| K970865 | Isg Family of Viewing WandsHAW · Traditional | 06/04/1997SE |
| K960714 | Isg Viewing WandHAW · Traditional | 05/29/1996SE |
| K941933 | Isg Medical Imaging Family of Workstations (Mifw)LLZ · Traditional | 07/29/1994SE |
| K911783 | Allegro Viewing WandLLZ · Traditional | 04/07/1994SE |
| K901679 | Resubmitted Isg 3DMV WorkstationLLZ · Traditional | 05/29/1990SE |
| K872150 | I.S.G. 3DMV WorkstationJAK · Traditional | 08/12/1987SE |
Questions and answers
When was SNN Fluoro Navigation System cleared by the FDA?
SNN Fluoro Navigation System (K993673) received a 510(k) decision of Substantially Equivalent on December 21, 1999, 50 days after the submission was received.
What is the product code of K993673?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.