510(k) · Cleared
ClearedOperating Arm System (Oas) [with CT and MR Images]
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 Oct 23, 1996 as substantially equivalent to K951262 (Radionics Software Applications, Inc., 1995) and 1 other predicate after a 163-day review. Its family tree reaches back 1 generation to 1994. 158 later devices descend from it.
- Decided
- Oct 23, 1996
- Review
- 163 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K911783 (1994). 2 ancestors in all. 158 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- This deviceK961844 Operating Arm System (Oas) [with CT and MR Images]Radionics Software Applications, Inc. · 1996
- Descendant · cites it directly · 152 of its ownK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- Descendant · 2 generations on · 151 of its ownK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- Descendant · 3 generations on · 146 of its ownK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
- Descendant · 3 generations on · 81 of its ownK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
- Descendant · 4 generations on · 78 of its ownK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
Showing 5 of 158 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 158 · See all- K984298Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999 · cites it directly152descendants
- K013025Modification to Flourolab PlusZ-Kat, Inc. · 2001 · 2 generations on151descendants
- K031454Acumen Surgical Navigation SystemBiomet, Inc. · 2004 · 3 generations on146descendants
- K031337Acumen Surgical Navigation SystemBiomet, Inc. · 2003 · 3 generations on81descendants
- K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · 4 generations on78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| 0 (this device) | K961844 | Operating Arm System (Oas) [with CT and MR Images] | Radionics Software Applications, Inc. | 1996 | — |
| +1 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| +2 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| +3 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
| +3 | K031337 | Acumen Surgical Navigation System | Biomet, Inc. | 2003 | — |
| +4 | K072806 | Mako Surgical Tactile Guidance System (TGS) | Mako Surgical Corp. | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 11 | 0 |
| 2018 | 2 | 0 |
| 2019 | 10 | 0 |
| 2020 | 12 | 0 |
| 2021 | 9 | 0 |
| 2022 | 14 | 0 |
| 2023 | 20 | 0 |
| 2024 | 14 | 0 |
| 2025 | 18 | 0 |
| 2026 | 11 | 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? (2)
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…l procedures, for example: tumor resection, ventricular shunt placement, craniotomy, and ENT- intranasal ethmoidectomy. Radionics Operating Arm System (with CT images), K951262; ISG Technologies Allegro Viewing Wand System, K911783; FLEXcon Company, Inc. Beekley XSpot stick-on fiducial markers included… | 1995 |
| * | K911783 | Allegro Viewing WandSummary page 1…shunt placement, craniotomy, and ENT- intranasal ethmoidectomy. Radionics Operating Arm System (with CT images), K951262; ISG Technologies Allegro Viewing Wand System, K911783; FLEXcon Company, Inc. Beekley XSpot stick-on fiducial markers included in RSA Operating Arm PMN, K951262. Radionics Software A… | 1994 |
What descends from it? (158)
See all 1583 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?
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?
OAS is a surgical planning system which enables the surgeon to plan a surgical procedure so as to optimize his approach. The OAS provides the surgeon with visual information to make assessments during a surgical procedure. OAS is indicated for the operative planning of surgical procedures, for example: tumor resection, ventricular shunt placement, craniotomy, and ENT-intranasal ethmoidectomy.
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/K961844 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961844: Operating Arm System (Oas) [with CT and MR Images].” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961844
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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