# K970865: Isg Family of Viewing Wands

- Pathway: 510(k) (Traditional)
- Applicant: I.S.G. Technologies, Inc.
- Decided: Jun 4, 1997 after 86 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K911783 (1994). 5 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960714: Isg Viewing Wand, I.S.G. Technologies, Inc. (1996) Summary page 1.
- K954276: Stealthstation, Surgical Navigation Technologies, Inc. (1996) Summary page 1.

## Most influential descendants
- K973684: Leksell Viewscope, Leksell Surgiscope, Leksell Freehand (1998), 1 descendant of its own
- K992882: Leksell Image Guidance Surgical System, View Scope, Surgiscope,Elekta Insight (1999), 0 descendants of its own
- K981480: Philips Easyguide (1999), 0 descendants of its own

## Indications for use
The Family of Viewing Wands, (including cranial and spinal applications) is comprised of a medical workstation and an integrated position sensing probe, is intended to be used pre-operatively and intra-operatively to perform the following functions: process and display pre-operatively radiographic images on a momtor; provide intra-operative image information based on the position and orientation of a user directed probe; allow for the optical integration and usage of different position sensing technologies (¢.g. articulated arm, infrared frechand) and surgical probes (handheld pointers); store/retrieve image data on computer access media (e.g. hard disks, archive media); and transmit data over local area and wide arca nctworks. Circumstances: The Family of Viewing Wands is intended to be used pre-operatively: whien more than one approach (e.g. eatry point, trajectory, craniotomy size, screw placement) is being considered; when determining the size of any instrumentation; and intra-operatively, when: the target, trajectory, or approach is in a region with few anatomical landmarks (e.g. subcortical brain) or with complex anatomy (e.g. scoliosis, fractures, deformuty); the target; trajectory, or-approach is net entircly exposed (e.g. posterior approach for screw placement); the target, trajectory, or approach is in a region wher¢ the normal landmarks have been distorted either by disease (e.g. degenerative disease, osteophytes) or by previous surgery; the target, trajectory, or approach is in close proximity to critical structures (e.g. venous sinuses, air sinuses, spinal ncrve roots or blood vessels) which must be avoided or negotiated; or the target’s delineation is important and will not move significantly during the approach (e.g. skull based tumors, sinus diseases, corpus callosotomies, spinal cord tumors). Disease or Conditions: The Family of Viewing Wands is indicated for patients who have space-occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations in the spine. The Family of Viewing Wands is contraindicated for patients suspected of having Creutzfeld-Jakob’s discasc if adequate sterilization of the instrument cannot be assured.

Source page: https://510kreport.com/device/K970865
Methodology: https://510kreport.com/methodology