Home / 510(k) Clearances / K993673

510(k) K993673

SNN FLUORO NAVIGATION SYSTEM by I.S.G. Technologies, Inc. — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1999
Date Received
November 1, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

Other clearances by I.S.G. Technologies, Inc.

  • K982570 — SNN SCOUT (January 13, 1999)
  • K980684 — VR NETSERVE (May 6, 1998)
  • K973413 — ID. STORE (RELEASE 2.0) (November 25, 1997)
  • K970865 — ISG FAMILY OF VIEWING WANDS (June 4, 1997)
  • K960714 — ISG VIEWING WAND (May 29, 1996)
  • K941933 — ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW) (July 29, 1994)
  • K911783 — ALLEGRO VIEWING WAND (April 7, 1994)
  • K901679 — RESUBMITTED ISG 3DMV WORKSTATION (May 29, 1990)
  • K872150 — I.S.G. 3DMV WORKSTATION (August 12, 1987)

Other clearances for product code HAW

  • K231897 — NeuroAlign software (October 21, 2025)
  • K251317 — SOLOPASS 2.0 System (September 5, 2025)
  • K250893 — Ball Joint Guide Array (66295) (September 4, 2025)
  • K250505 — EZ-FIDUCIALS (July 9, 2025)
  • K242575 — Stereotaxic Guiding Surgical Devices, NaoTrac S (May 23, 2025)
  • K241327 — Navient Image Guide Navigation System (955-NC-NC), Cranial (February 5, 2025)
  • K243698 — Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignm (January 28, 2025)
  • K243657 — ClearPoint System (Software Version 3.0) (January 24, 2025)
  • K241333 — Geniant Cranial (Navigated Neurosurgical Positioning Robot) (January 17, 2025)
  • K242480 — FLASH EVD System (10-0002) (December 27, 2024)