510(k) Report

510(k) · Cleared

Cleared

Leksell Image Guidance Surgical System (Ligs)

K961639510(k) TraditionalCleared Jul 26, 199688-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

Elekta Instrument AB · HAW Neurological Stereotaxic Instrument

Cleared on Jul 26, 1996 as substantially equivalent to K943468 (Elekta Instruments, Inc., 1995) and 3 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.

Decided
Jul 26, 1996
Review
88 days
Class
Class II
Product code
HAW
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K920689 (1993). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1998: 1 descendant cleared1999: 1 descendant clearedK920689 · Deemed MSS -- Microscope Support System · Deemed, Inc. · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K920689 · Deemed MSS -- Microscope Support System · Deemed, Inc. · 19930
  1. Root · 1 generation backK920689 Deemed MSS -- Microscope Support SystemDeemed, Inc. · 1993
  2. This deviceK961639 Leksell Image Guidance Surgical System (Ligs)Elekta Instrument AB · 1996
  3. Descendant · cites it directly · 1 of its ownK973684 Leksell Viewscope, Leksell Surgiscope, Leksell FreehandElekta Instrument AB · 1998
  4. Descendant · 2 generations on · 0 of its ownK992882 Leksell Image Guidance Surgical System, View Scope…Elekta Instrument AB · 1999

Most influential descendants

Showing 2 of 2 · See all
  • K973684Leksell Viewscope, Leksell Surgiscope, Leksell FreehandElekta Instrument AB · 1998 · cites it directly1descendant
  • K992882Leksell Image Guidance Surgical System, View Scope, Surgiscope,Elekta InsightElekta Instrument AB · 1999 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K920689Deemed MSS -- Microscope Support SystemDeemed, Inc.1993—
0 (this device)K961639Leksell Image Guidance Surgical System (Ligs)Elekta Instrument AB1996—
+1K973684Leksell Viewscope, Leksell Surgiscope, Leksell FreehandElekta Instrument AB1998—
+2K992882Leksell Image Guidance Surgical System, View Scope, Surgiscope,Elekta InsightElekta Instrument AB1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
FIG. 1 — Lineage of K961639, 1993–1999Source: 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
*K943468Leksell Surgiplan
Summary page 3
…10(k) SUBMISSION LEKSELL IMAGE GUIDANCE SURGICAL SYSTEM 20.3 IDENTIFICATION OF PREDICATE DEVICE Company Device 510(k) No. Date Cleared Elekta Instruments AB SurgiPlan K943468 1-20-95 DeeMed Internations Microscope Support K920689 11-12-93 System (MSS) Surgical Navigation Stealth System K954276 1-24-96…
Elekta Instruments, Inc.19951
*K920689Deemed MSS -- Microscope Support System
Summary page 3
…20.3 IDENTIFICATION OF PREDICATE DEVICE Company Device 510(k) No. Date Cleared Elekta Instruments AB SurgiPlan K943468 1-20-95 DeeMed Internations Microscope Support K920689 11-12-93 System (MSS) Surgical Navigation Stealth System K954276 1-24-96 Technology Zeiss Zeiss Multiple Coordinate K942233 7-…
Deemed, Inc.1993—
*K954276Stealthstation
Summary page 3
…. Date Cleared Elekta Instruments AB SurgiPlan K943468 1-20-95 DeeMed Internations Microscope Support K920689 11-12-93 System (MSS) Surgical Navigation Stealth System K954276 1-24-96 Technology Zeiss Zeiss Multiple Coordinate K942233 7-1-94 Manipulator System (MKM) 20.4. DEVICE DESCRIPTION The Lekse…
Surgical Navigation Technologies, Inc.19961
*K942233MKM (Multiple Coordinate Manipulator) System
Summary page 3
…95 DeeMed Internations Microscope Support K920689 11-12-93 System (MSS) Surgical Navigation Stealth System K954276 1-24-96 Technology Zeiss Zeiss Multiple Coordinate K942233 7-1-94 Manipulator System (MKM) 20.4. DEVICE DESCRIPTION The Leksell Image Guidance Surgical System (LIGS) device provides imag…
Carl Zeiss, Inc.1994—

Also cleared against K943468: 1 other device →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
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?

  • 2 of the 4 ancestors have a recall of any class.
  • Of its descendants, K973684 (Elekta Instrument AB, 1998) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K943468.

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—

What is it indicated for?

The Leksell Image Guidance Surgical System (LIGS) is intended for use in neurosurgical procedures to provide image guidance based on preoperative images which are visualized interactively with the aid of surgical tools.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K943468

1 other device cites the same predicate.

  • K013861Modification to Leksell Surgiplan with AtlaspaceElekta Instrument AB · 2001

More from Elekta Instrument AB

35 FDA decisions under this applicant name. See the company

  • K190887Leksell Vantage Stereotactic SystemElekta Instrument AB · 20193 recalls
  • K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018
  • K173791Leksell GammaPlanElekta Instrument AB · 20182 recalls
  • K171123Leksell Vantage Stereotactic SystemElekta Instrument AB · 20172 recalls
  • K160440Leksell Gamma Knife IconElekta Instrument AB · 20161 recall

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/K961639 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961639: Leksell Image Guidance Surgical System (Ligs).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961639

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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