510(k) Report

510(k) · Cleared

Cleared

Optical Tracking System (Ots)

K990632510(k) TraditionalCleared Apr 29, 199962-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

Radionics, Inc. · HAW Neurological Stereotaxic Instrument

Cleared on Apr 29, 1999 as substantially equivalent to K964801 (Radionics Software Applications, Inc., 1997) and 3 other predicates after a 62-day review. Its family tree reaches back 4 generations to 1994.

Decided
Apr 29, 1999
Review
62 days
Class
Class II
Product code
HAW
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K911783 (1994). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestorK911783 · Allegro Viewing Wand · I.S.G. Technologies, Inc. · 1994K961844 · Operating Arm System (Oas) [with CT and MR Images] · Radionics Software Applications, Inc. · 1996K964801 · Optical Tracking System (Ots) · Radionics Software Applications, Inc. · 1997K974602 · Optical Tracking System (Ots) · Radionics Software Applications, Inc. · 1998199019921994199619982000
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor K974602 · Optical Tracking System (Ots) · Radionics Software Applications, Inc. · 1998K964801 · Optical Tracking System (Ots) · Radionics Software Applications, Inc. · 1997K961844 · Operating Arm System (Oas) [with CT and MR Images] · Radionics Software Applications, Inc. · 1996K911783 · Allegro Viewing Wand · I.S.G. Technologies, Inc. · 19940
  1. Root · 4 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
  2. 3 generations backK961844 Operating Arm System (Oas) [with CT and MR Images]Radionics Software Applications, Inc. · 1996
  3. 2 generations backK964801 Optical Tracking System (Ots)Radionics Software Applications, Inc. · 1997
  4. 1 generation backK974602 Optical Tracking System (Ots)Radionics Software Applications, Inc. · 1998
  5. This deviceK990632 Optical Tracking System (Ots)Radionics, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K911783Allegro Viewing WandI.S.G. Technologies, Inc.1994—
−3K961844Operating Arm System (Oas) [with CT and MR Images]Radionics Software Applications, Inc.1996—
−2K964801Optical Tracking System (Ots)Radionics Software Applications, Inc.1997—
−1K974602Optical Tracking System (Ots)Radionics Software Applications, Inc.1998—
0 (this device)K990632Optical Tracking System (Ots)Radionics, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199610
199710
FIG. 1 — Lineage of K990632, 1994–1999Source: 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
*K964801Optical Tracking System (Ots)
Summary page 1
…raoperative Guidance Device Proprietary Name: Radionics Optical Tracking System (OTS) 3. This device is substantially equivalent to: Radionics Optical Tracking System [K964801, K974602] Surgical Navigation Technologies StealthStation Stereotactic System [K954276, K971247]. 4. The submission describes a…
Radionics Software Applications, Inc.1997—
*K974602Optical Tracking System (Ots)
Summary page 1
…ve Guidance Device Proprietary Name: Radionics Optical Tracking System (OTS) 3. This device is substantially equivalent to: Radionics Optical Tracking System [K964801, K974602] Surgical Navigation Technologies StealthStation Stereotactic System [K954276, K971247]. 4. The submission describes a revised…
Radionics Software Applications, Inc.1998—
*K954276Stealthstation
Summary page 1
…. This device is substantially equivalent to: Radionics Optical Tracking System [K964801, K974602] Surgical Navigation Technologies StealthStation Stereotactic System [K954276, K971247]. 4. The submission describes a revised indications for use for the Optical Tracking System to provide for use in frame…
Surgical Navigation Technologies, Inc.19961
*K971247SNT Disposable Biopsy Needle
Summary page 1
…vice is substantially equivalent to: Radionics Optical Tracking System [K964801, K974602] Surgical Navigation Technologies StealthStation Stereotactic System [K954276, K971247]. 4. The submission describes a revised indications for use for the Optical Tracking System to provide for use in frameless cran…
Surgical Navigation Technologies, Inc.19976

Also cleared against K964801: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • 1 other device also cites its predicate K964801.

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 OTS is a graphical planning tool that allows for preoperative planning of, and intraoperative navigation during, cranial and spinal surgical procedures. This includes use in frameless cranial biopsy procedures.

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 K964801

1 other device cites the same predicate.

  • K974602Optical Tracking System (Ots)Radionics Software Applications, Inc. · 1998

More from Radionics, Inc.

56 FDA decisions under this applicant name. See the company

  • K030697Radionics Single Use Ground Pad (DGP-HP)Radionics, Inc. · 20031 recall
  • K001741Radionics RF Disc Catheter Electrode SystemRadionics, Inc. · 2000
  • K002773Neuromap with Neuro 100Radionics, Inc. · 2000
  • K992226XDS External CSF Drainage and Monitoring SystemRadionics, Inc. · 2000
  • K001950Optical Tracking System (Ots)Radionics, Inc. · 2000

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/K990632 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990632: Optical Tracking System (Ots).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990632

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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