510(k) Report

510(k) · Cleared

Cleared

Omni V SBRT Positioning System, Model RT-4500

K100691510(k) TraditionalCleared May 11, 201062-day reviewClass II21 CFR 892.5050

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

Bionix Development Corp. · IYE Accelerator, Linear, Medical

Cleared on May 11, 2010 as substantially equivalent to K013391 (Medical Intelligence Medizintechnik GmbH, 2002) and 1 other predicate after a 62-day review. Its family tree reaches back 4 generations to 1994. 6 later devices descend from it.

Decided
May 11, 2010
Review
62 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K935300 (1994). 10 ancestors in all, the oldest K854886 (1986). 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1990: 1 other ancestor1986: 1 other ancestor2013: 1 descendant cleared2018: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant clearedK935300 · Vac-Lok Immobilization System · Medtec, Inc. · 1994K960338 · Stereotactic Body Frame · Elekta Instrument AB · 1996K970291 · Accessories to the Stereotactic Body Fram · Elekta Instrument AB · 1997K991336 · Bodyloc Whole Body Stereotactic Localizer System for Radiotherapy · Medical Instrumentation & Diagnostics Corp.(Midco) · 19991990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 3 other ancestors4 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K991336 · Bodyloc Whole Body Stereotactic Localizer System for Radiotherapy · Medical Instrumentation & Diagnostics Corp.(Midco) · 1999K970291 · Accessories to the Stereotactic Body Fram · Elekta Instrument AB · 1997K960338 · Stereotactic Body Frame · Elekta Instrument AB · 1996K935300 · Vac-Lok Immobilization System · Medtec, Inc. · 19940
  1. Root · 4 generations backK935300 Vac-Lok Immobilization SystemMedtec, Inc. · 1994
  2. 3 generations backK960338 Stereotactic Body FrameElekta Instrument AB · 1996
  3. 2 generations backK970291 Accessories to the Stereotactic Body FramElekta Instrument AB · 1997
  4. 1 generation backK991336 Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco) · 1999
  5. This deviceK100691 Omni V SBRT Positioning System, Model RT-4500Bionix Development Corp. · 2010
  6. Descendant · cites it directly · 5 of its ownK122888 CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013
  7. Descendant · 2 generations on · 3 of its ownK153026 Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body…Medtec, Inc. D/B/A Civco Medical Solutions · 2016
  8. Descendant · 3 generations on · 1 of its ownK210894 Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021
  9. Descendant · 4 generations on · 0 of its ownK222762 Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd. · 2023
  10. Descendant · 2 generations on · 0 of its ownK182079 Solstice SRS Immobilization System; Solstat Immobilization System…Medtec Inc. Dba Civco Medical Solutions · 2018 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2013: 12016: 12017: 12018: 12021: 12023: 1
2013high 1 (2013) · low 0 (2014)2026

Most influential descendants

Showing 5 of 6 · See all
  • K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013 · cites it directly5descendants
  • K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt…Medtec, Inc. D/B/A Civco Medical Solutions · 2016 · 2 generations on3descendants
  • K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021 · 3 generations on1descendant
  • K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd. · 2023 · 4 generations on0descendants
  • K182079Solstice SRS Immobilization System; Solstat Immobilization System; Solstice…Medtec Inc. Dba Civco Medical Solutions · 2018 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K935300Vac-Lok Immobilization SystemMedtec, Inc.1994—
−3K960338Stereotactic Body FrameElekta Instrument AB1996—
−2K970291Accessories to the Stereotactic Body FramElekta Instrument AB1997—
−1K991336Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco)1999—
0 (this device)K100691Omni V SBRT Positioning System, Model RT-4500Bionix Development Corp.2010—
+1K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc.2013—
+2K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body…Medtec, Inc. D/B/A Civco Medical Solutions2016—
+3K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd.2021—
+4K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd.2023—
+2K182079Solstice SRS Immobilization System; Solstat Immobilization System; Solstice…Medtec Inc. Dba Civco Medical Solutions20181

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
199010
199510
199610
199810
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201610
201710
201810
202110
202310
FIG. 1 — Lineage of K100691, 1994–2023Source: 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 IYE? 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 IYE device

  1. #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K013391Bodyfix
Summary page 1
…er regulation number 892.5050, Accessory, Accelerator, Linear, Medical, and is classified as a Class II device. This device has been cleared by the FDA under K013391. Bionix Development Corporation Page…
Medical Intelligence Medizintechnik GmbH2002—
*K991336Bodyloc Whole Body Stereotactic Localizer System for Radiotherapy
Summary page 2
…regulation number 892.5050, Accessory, Accelerator, Linear, Medical, and is classified as a Class II device. This device has been cleared by the FDA under K99 1336. The MIDGO BodyLoc system is designed to immobilize and position patients for a course of stereotactic radiation t…
Medical Instrumentation & Diagnostics Corp.(Midco)1999—

Also cleared against K013391: 1 other device →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc.20135

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 16 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
  • 1 of the 10 ancestors has a recall of any class.
  • Of its descendants, K122888 (Cdr Systems, Inc., 2013) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K013391.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · IYE

12in 2025

2007: 232008: 142009: 202010: 232011: 112012: 282013: 182014: 202015: 202016: 212017: 232018: 212019: 192020: 202021: 192022: 122023: 182024: 92025: 122026 (partial year): 14
2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007: 44 days median2008: 69 days median2009: 63 days median2010: 74 days median2011: 94 days median2012: 106 days median2013: 88 days median2014: 100 days median2015: 108 days median2016: 97 days median2017: 94 days median2018: 58 days median2019: 83 days median2020: 67 days median2021: 86 days median2022: 172 days median2023: 129 days median2024: 239 days median2025: 170 days median2026 (partial year): 120 days median
2007high 239 (2024) · low 44 (2007)2026

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

Recalls per year · IYE

1in 2025

2007: 782008: 492009: 222010: 272011: 732012: 202013: 112014: 142015: 82016: 72017: 72018: 72019: 22020: 42021: 52022: 32023: 72024: 12025: 12026 (partial year): 4
2007high 78 (2007) · low 1 (2024)2026

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

Adverse event reports per year · IYE

101in 2025

2007: 1552008: 1142009: 1742010: 2462011: 2802012: 1282013: 962014: 1242015: 1002016: 972017: 1252018: 852019: 912020: 742021: 682022: 662023: 1282024: 812025: 101
2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, 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
2007234478155
2008146949114
2009206322174
2010237427246
2011119473280
20122810620128
201318881196
20142010014124
2015201088100
20162197797
201723947125
20182158785
20191983291
20202067474
20211986568
202212172366
2023181297128
20249239181
2025121701101
2026141204—

What is it indicated for?

The Omni V SBRT Positioning System developed and manufactured by Bionix Development Corp., Toledo, Ohio, is intended to be used for stereotactic localization and positioning of patients undergoing or receiving a course of external beam radiation therapy for the treatment of cancer and other diseases.

It is intended to be used by or under the direction of a licensed physician.

Indications for use as stated in the FDA summary.

Also cleared against K013391

1 other device cites the same predicate.

  • K121530Bodyfix SystemMedical Intelligence Medizintechnik GmbH · 2012

More from Bionix Development Corp.

12 FDA decisions under this applicant name. See the company

  • K153270TruGuard Custom Tongue and Jaw PositionerBionix Development Corp. · 2016
  • K123411Little Angels Swaddling BlanketBionix Development Corp. · 2013
  • K120335Embrace ThermoplasticBionix Development Corp. · 2012
  • K100264T-Form Extremity Immobilizer, Model RT-6060Bionix Development Corp. · 2010
  • K050701Thigh and Foot Positioner, Suprone Plus, Model RT-6010Bionix Development Corp. · 2005

Recent decisions in IYE

The IYE category page

  • K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC · 2026
  • K261718EZFluence (RADEZ V2)Radformation, Inc. · 2026
  • K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
  • K252937ThinkQA 3Dosisoft SA · 2026

https://510kreport.com/device/K100691 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100691: Omni V SBRT Positioning System, Model RT-4500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100691

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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