510(k) · Cleared
ClearedOptical Tracking System (Ots)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radionics Software Applications, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jun 2, 1997 as substantially equivalent to K951262 (Radionics Software Applications, Inc., 1995) and 2 other predicates after a 185-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it.
- Decided
- Jun 2, 1997
- Review
- 185 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K911783 (1994). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 1 generation backK961844 Operating Arm System (Oas) [with CT and MR Images]Radionics Software Applications, Inc. · 1996
- This deviceK964801 Optical Tracking System (Ots)Radionics Software Applications, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK974602 Optical Tracking System (Ots)Radionics Software Applications, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK990632 Optical Tracking System (Ots)Radionics, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK983669 Optical Tracking System with Surface Matching Module, Model OtsRadionics, Inc. · 1998
Most influential descendants
Showing 3 of 3 · See all- K974602Optical Tracking System (Ots)Radionics Software Applications, Inc. · 1998 · cites it directly2descendants
- K990632Optical Tracking System (Ots)Radionics, Inc. · 1999 · cites it directly0descendants
- K983669Optical Tracking System with Surface Matching Module, Model OtsRadionics, Inc. · 1998 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −1 | K961844 | Operating Arm System (Oas) [with CT and MR Images] | Radionics Software Applications, Inc. | 1996 | — |
| 0 (this device) | K964801 | Optical Tracking System (Ots) | Radionics Software Applications, Inc. | 1997 | — |
| +1 | K974602 | Optical Tracking System (Ots) | Radionics Software Applications, Inc. | 1998 | — |
| +1 | K990632 | Optical Tracking System (Ots) | Radionics, Inc. | 1999 | — |
| +2 | K983669 | Optical Tracking System with Surface Matching Module, Model Ots | Radionics, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
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 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951262 | Operating Arm System (Oas)Summary page 1…ures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures. Predicate Devices: Radionics Operating Arm System, K951262 and K961844; StealthStation: Stereotactic System, manufactured by Surgical Navigation Technologies, Inc., K954276. Establishmen… | 1995 |
| * | K961844 | Operating Arm System (Oas) [with CT and MR Images]Summary page 1…h anatomical landmarks are not clearly visible or where a desired target is close to critical structures. Predicate Devices: Radionics Operating Arm System, K951262 and K961844; StealthStation: Stereotactic System, manufactured by Surgical Navigation Technologies, Inc., K954276. Establishment Name and A… | 1996 |
| * | K954276 | StealthstationSummary page 1…s. Predicate Devices: Radionics Operating Arm System, K951262 and K961844; StealthStation: Stereotactic System, manufactured by Surgical Navigation Technologies, Inc., K954276. Establishment Name and Address: Radionics Software Applications, Inc. 22 Terry Avenue Burlington, MA 01803 Contact Name and Ph… | 1996 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K974602 (Radionics Software Applications, Inc., 1998) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K951262.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The Optical Tracking System (OTS) is a graphical planning tool that allows for pre-operative and operative planning of surgical procedures. The OTS is indicated for use in surgical procedures in which anatomical landmarks are noi clearly visible or where a desired target is close to critical structures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964801 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964801: 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/K964801
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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