510(k) Report

510(k) · Cleared

Cleared

Isg Viewing Wand

K960714510(k) TraditionalCleared May 29, 199698-day reviewClass II21 CFR 882.4560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

I.S.G. Technologies, Inc. · HAW Neurological Stereotaxic Instrument

Cleared on May 29, 1996 as substantially equivalent to K911783 (I.S.G. Technologies, Inc., 1994) and 2 other predicates after a 98-day review. Its family tree reaches back 1 generation to 1994. 71 later devices descend from it.

Decided
May 29, 1996
Review
98 days
Class
Class II
Product code
HAW
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K911783 (1994). 3 ancestors in all. 71 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 2 other ancestors1998: 2 descendants cleared1997: 2 descendants cleared2014: 3 descendants cleared1999: 2 descendants cleared2016: 7 descendants cleared2020: 11 descendants cleared2015: 2 descendants cleared2017: 6 descendants cleared2021: 2 descendants cleared2004: 1 descendant cleared2007: 1 descendant cleared2008: 1 descendant cleared2005: 1 descendant cleared2022: 1 descendant cleared2018: 7 descendants cleared2026: 7 descendants cleared2010: 1 descendant cleared2019: 1 descendant cleared2023: 5 descendants cleared2011: 3 descendants cleared2012: 1 descendant cleared2024: 1 descendant cleared2025: 3 descendants clearedK911783 · Allegro Viewing Wand · I.S.G. Technologies, Inc. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 9 descendants4 generations forward: 17 descendants5 generations forward: 6 descendants6 generations forward: 3 descendants7 generations forward: 4 descendants8 generations forward: 4 descendants9 generations forward: 2 descendants10 generations forward: 2 descendants11 generations forward: 1 descendant12 generations forward: 1 descendant13 generations forward: 1 descendant14 generations forward: 2 descendants15 generations forward: 5 descendants16 generations forward: 5 descendants17 generations forward: 2 descendants K911783 · Allegro Viewing Wand · I.S.G. Technologies, Inc. · 19940+5+10+15
  1. Root · 1 generation backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
  2. This deviceK960714 Isg Viewing WandI.S.G. Technologies, Inc. · 1996
  3. Descendant · cites it directly · 66 of its ownK964229 Regulus NavigatorCompass Intl., Inc. · 1997
  4. Descendant · 2 generations on · 36 of its ownK981315 NavitrackOrthosoft, Inc. · 1998
  5. Descendant · 3 generations on · 35 of its ownK033413 Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004
  6. Descendant · 4 generations on · 34 of its ownK051676 Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005
  7. Descendant · 4 generations on · 33 of its ownK063607 Spineassist SystemMazor Surgical Technologies, Ltd. · 2007

Showing 5 of 71 descendants. See all descendants

Descendants cleared per year

1997: 21998: 21999: 22004: 12005: 12007: 12008: 12010: 12011: 32012: 12014: 32015: 22016: 72017: 62018: 72019: 12020: 112021: 22022: 12023: 52024: 12025: 32026: 7
1997high 11 (2020) · low 0 (2000)2026

Most influential descendants

Showing 5 of 71 · See all
  • K964229Regulus NavigatorCompass Intl., Inc. · 1997 · cites it directly66descendants
  • K981315NavitrackOrthosoft, Inc. · 1998 · 2 generations on36descendants
  • K033413Spineassist DeviceMazor Surgical Technologies, Ltd. · 2004 · 3 generations on35descendants
  • K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd. · 2005 · 4 generations on34descendants
  • K063607Spineassist SystemMazor Surgical Technologies, Ltd. · 2007 · 4 generations on33descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K911783Allegro Viewing WandI.S.G. Technologies, Inc.1994—
0 (this device)K960714Isg Viewing WandI.S.G. Technologies, Inc.1996—
+1K964229Regulus NavigatorCompass Intl., Inc.1997—
+2K981315NavitrackOrthosoft, Inc.1998—
+3K033413Spineassist DeviceMazor Surgical Technologies, Ltd.2004—
+4K051676Spineassist Device with Additional AccessoriesMazor Surgical Technologies, Ltd.2005—
+4K063607Spineassist SystemMazor Surgical Technologies, Ltd.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199820
199920
200410
200510
200710
200810
201010
201130
201210
201430
201520
201670
201760
201870
201910
2020110
202120
202210
202350
202410
202530
202670
FIG. 1 — Lineage of K960714, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HAW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new HAW device

  1. #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K911783Allegro Viewing Wand
Summary page 2
…ewing Wands as described in this submission is substantially equivalent to the Allegro Viewing Wand by ISG Technologies Inc. which was the subject matter of 510(k) file ¥K911783 and which is currently being marketed by ISG Technologies, Incorporated. The Family of Viewing Wands also incorporates some of th…
I.S.G. Technologies, Inc.1994—
*K951262Operating Arm System (Oas)
Summary page 2
…lly equivalent to other legally marketed devices, including the Zeiss mmmmfl———ummm); the Radionics OAS (Operating Arm System) neurosurgery planning and guidance system (¥K951262); and the Codman Acustar I Advanced Surgical Navigation System (¥K944612). Performance Standards: There are currently no Sectio…
Radionics Software Applications, Inc.1995—
*K944612Acustar I Advanced Surgical Navigation System
Summary page 2
…mfl———ummm); the Radionics OAS (Operating Arm System) neurosurgery planning and guidance system (¥K951262); and the Codman Acustar I Advanced Surgical Navigation System (¥K944612). Performance Standards: There are currently no Section 514 performance standards applicable to systems of this type. Standards…
Codman & Shurtleff, Inc.1995—
*—Zeiss
Named without a submission number
—

Also cleared against K911783: 7 other devices →

What descends from it? (71)

See all 71

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K964229Regulus NavigatorCompass Intl., Inc.199766
K970865Isg Family of Viewing WandsI.S.G. Technologies, Inc.19973
K973684Leksell Viewscope, Leksell Surgiscope, Leksell FreehandElekta Instrument AB19981

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K964229 (Compass Intl., Inc., 1997) has gone furthest, with 66 descendants of its own.
  • 7 other devices also cite its predicate K911783.

How does its category compare?

All HAW devices

HAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HAW

9in 2025

2007: 152008: 122009: 82010: 62011: 42012: 82013: 32014: 52015: 102016: 92017: 72018: 62019: 102020: 52021: 92022: 72023: 142024: 72025: 92026 (partial year): 5
2007high 15 (2007) · low 3 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HAW

163in 2025

2007: 107 days median2008: 112 days median2009: 221 days median2010: 138 days median2011: 66 days median2012: 178 days median2013: 172 days median2014: 238 days median2015: 232 days median2016: 175 days median2017: 226 days median2018: 112 days median2019: 147 days median2020: 88 days median2021: 168 days median2022: 128 days median2023: 142 days median2024: 107 days median2025: 163 days median2026 (partial year): 162 days median
2007high 238 (2014) · low 66 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HAW

2in 2025

2007: 22008: 102009: 62010: 282011: 52012: 42013: 6, 1 Class I2014: 52015: 32016: 52017: 22018: 2, 2 Class I2019: 4, 1 Class I2020: 12021: 4, 2 Class I2022: 12023: 4, 1 Class I2024: 2, 2 Class I2025: 22026 (partial year): 6
2007high 28 (2010) · low 1 (2020)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · HAW

3,425in 2025

2007: 492008: 532009: 962010: 2992011: 1,7252012: 9862013: 1,2902014: 1,6062015: 1,7672016: 1,8282017: 3,5052018: 4,4392019: 6,0622020: 3,4802021: 2,8272022: 1,9292023: 2,5102024: 3,7552025: 3,425
2007high 6,062 (2019) · low 49 (2007)2025

MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200715107249
2008121121053
20098221696
2010613828299
201146651,725
201281784986
201331726 (1)1,290
2014523851,606
20151023231,767
2016917551,828
2017722623,505
201861122 (2)4,439
2019101474 (1)6,062
202058813,480
202191684 (2)2,827
2022712811,929
2023141424 (1)2,510
202471072 (2)3,755
2025916323,425
202651626—

Also cleared against K911783

7 other devices cite the same predicate.

  • K983529Instatrak 3000Visualization Technology, Inc. · 19981 Class I recall
  • K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 19981 Class I recall
  • K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 19981 Class I recall
  • K961834Philips Easyguide NeuroPhilips Medical Systems, Inc. · 1996
  • K961844Operating Arm System (Oas) [with CT and MR Images]Radionics Software Applications, Inc. · 1996
  • K961168ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996

More from I.S.G. Technologies, Inc.

10 FDA decisions under this applicant name. See the company

  • K993673SNN Fluoro Navigation SystemI.S.G. Technologies, Inc. · 1999
  • K982570SNN ScoutI.S.G. Technologies, Inc. · 1999
  • K980684VR NetserveI.S.G. Technologies, Inc. · 1998
  • K973413ID. Store (Release 2.0)I.S.G. Technologies, Inc. · 1997
  • K970865Isg Family of Viewing WandsI.S.G. Technologies, Inc. · 1997

Recent decisions in HAW

The HAW category page

  • K262214Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)Guangzhou Aimooe Technology Co., Ltd. · 2026
  • K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc. · 2026
  • K261932Leksell® Vantage Stereotactic SystemElekta Solutions AB · 2026
  • K253663Zeta Navigation SystemZeta Surgical, Inc. · 2026
  • K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc. · 2026

https://510kreport.com/device/K960714 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960714: Isg Viewing Wand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960714

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026