510(k) Report

510(k) · Cleared

Cleared

Operating Arm System (Oas)

K951262510(k) TraditionalCleared Nov 13, 1995237-day reviewClass II21 CFR 892.2050

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

Radionics Software Applications, Inc. · LLZ System, Image Processing, Radiological

Cleared on Nov 13, 1995 after a 237-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 232 later devices descend from it.

Decided
Nov 13, 1995
Review
237 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

232 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1996: 3 descendants cleared1997: 3 descendants cleared1998: 5 descendants cleared1999: 4 descendants cleared2014: 5 descendants cleared2001: 1 descendant cleared2003: 2 descendants cleared2004: 2 descendants cleared2016: 12 descendants cleared2020: 23 descendants cleared2015: 8 descendants cleared2017: 17 descendants cleared2021: 11 descendants cleared2008: 3 descendants cleared2005: 2 descendants cleared2012: 5 descendants cleared2007: 1 descendant cleared2022: 15 descendants cleared2018: 9 descendants cleared2026: 18 descendants cleared2006: 1 descendant cleared2009: 2 descendants cleared2010: 2 descendants cleared2013: 3 descendants cleared2019: 11 descendants cleared2023: 25 descendants cleared2011: 3 descendants cleared2025: 21 descendants cleared2024: 15 descendants cleared1995200020052010201520202025
  1. This deviceK951262 Operating Arm System (Oas)Radionics Software Applications, Inc. · 1995
  2. Descendant · cites it directly · 158 of its ownK961844 Operating Arm System (Oas) [with CT and MR Images]Radionics Software Applications, Inc. · 1996
  3. Descendant · 2 generations on · 152 of its ownK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
  4. Descendant · 3 generations on · 151 of its ownK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
  5. Descendant · 4 generations on · 146 of its ownK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
  6. Descendant · 4 generations on · 81 of its ownK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003

Showing 5 of 232 descendants. See all descendants

Descendants cleared per year

1996: 31997: 31998: 51999: 42001: 12003: 22004: 22005: 22006: 12007: 12008: 32009: 22010: 22011: 32012: 52013: 32014: 52015: 82016: 122017: 172018: 92019: 112020: 232021: 112022: 152023: 252024: 152025: 212026: 18
1996high 25 (2023) · low 0 (2000)2026

Most influential descendants

Showing 5 of 232 · See all
  • K961844Operating Arm System (Oas) [with CT and MR Images]Radionics Software Applications, Inc. · 1996 · cites it directly158descendants
  • K984298Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999 · 2 generations on152descendants
  • K013025Modification to Flourolab PlusZ-Kat, Inc. · 2001 · 3 generations on151descendants
  • K031454Acumen Surgical Navigation SystemBiomet, Inc. · 2004 · 4 generations on146descendants
  • K031337Acumen Surgical Navigation SystemBiomet, Inc. · 2003 · 4 generations on81descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951262Operating Arm System (Oas)Radionics Software Applications, Inc.1995—
+1K961844Operating Arm System (Oas) [with CT and MR Images]Radionics Software Applications, Inc.1996—
+2K984298Z Kat Flurotactic Guidance System MkiZ-Kat, Inc.1999—
+3K013025Modification to Flourolab PlusZ-Kat, Inc.2001—
+4K031454Acumen Surgical Navigation SystemBiomet, Inc.2004—
+4K031337Acumen Surgical Navigation SystemBiomet, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199630
199730
199850
199940
200110
200320
200420
200520
200610
200710
200830
200920
201020
201130
201250
201330
201450
201580
2016120
2017170
201890
2019110
2020230
2021110
2022150
2023250
2024150
2025210
2026180
FIG. 1 — Lineage of K951262, 1995–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LLZ? 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 LLZ device

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (232)

See all 232

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

NumberDeviceApplicantDecidedDescendants
K961844Operating Arm System (Oas) [with CT and MR Images]Radionics Software Applications, Inc.1996158
K960714Isg Viewing WandI.S.G. Technologies, Inc.199671
K964801Optical Tracking System (Ots)Radionics Software Applications, Inc.19973
K961834Philips Easyguide NeuroPhilips Medical Systems, Inc.19960

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?

  • Of its descendants, K961844 (Radionics Software Applications, Inc., 1996) has gone furthest, with 158 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

More from Radionics Software Applications, Inc.

12 FDA decisions under this applicant name. See the company

  • K990326Optical Tracking System Microscope Module II, Model Ots MmiiRadionics Software Applications, Inc. · 1999
  • K974602Optical Tracking System (Ots)Radionics Software Applications, Inc. · 1998
  • K972905XPLAN-1Radionics Software Applications, Inc. · 1997
  • K964801Optical Tracking System (Ots)Radionics Software Applications, Inc. · 1997
  • K961844Operating Arm System (Oas) [with CT and MR Images]Radionics Software Applications, Inc. · 1996

Recent decisions in LLZ

The LLZ category page

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  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K951262 · printed Nov 4, 2026

Cite this page

510(k) Report. “K951262: Operating Arm System (Oas).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951262

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026