510(k) · Cleared
ClearedCDR Systems Precision Patient Positioning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cdr Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Apr 30, 2013 as substantially equivalent to K100691 (Bionix Development Corp., 2010) and 4 other predicates after a 222-day review. Its family tree reaches back 5 generations to 1994. 5 later devices descend from it.
- Decided
- Apr 30, 2013
- Review
- 222 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K935300 (1994). 33 ancestors in all, the oldest K854886 (1986). 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK935300 Vac-Lok Immobilization SystemMedtec, Inc. · 1994
- 4 generations backK960338 Stereotactic Body FrameElekta Instrument AB · 1996
- 3 generations backK970291 Accessories to the Stereotactic Body FramElekta Instrument AB · 1997
- 2 generations backK991336 Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco) · 1999
- 1 generation backK100691 Omni V SBRT Positioning System, Model RT-4500Bionix Development Corp. · 2010
- This deviceK122888 CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK153026 Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body…Medtec, Inc. D/B/A Civco Medical Solutions · 2016
- Descendant · 2 generations on · 1 of its ownK210894 Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK222762 Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK182079 Solstice SRS Immobilization System; Solstat Immobilization System…Medtec Inc. Dba Civco Medical Solutions · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK171133 Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution…Qfix · 2017
Most influential descendants
Showing 5 of 5 · See all- K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt…Medtec, Inc. D/B/A Civco Medical Solutions · 2016 · cites it directly3descendants
- K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021 · 2 generations on1descendant
- K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd. · 2023 · 3 generations on0descendants
- K182079Solstice SRS Immobilization System; Solstat Immobilization System; Solstice…Medtec Inc. Dba Civco Medical Solutions · 2018 · cites it directly0descendants
- K171133Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and AccessoriesQfix · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K935300 | Vac-Lok Immobilization System | Medtec, Inc. | 1994 | — |
| −4 | K960338 | Stereotactic Body Frame | Elekta Instrument AB | 1996 | — |
| −3 | K970291 | Accessories to the Stereotactic Body Fram | Elekta Instrument AB | 1997 | — |
| −2 | K991336 | Bodyloc Whole Body Stereotactic Localizer System for Radiotherapy | Medical Instrumentation & Diagnostics Corp.(Midco) | 1999 | — |
| −1 | K100691 | Omni V SBRT Positioning System, Model RT-4500 | Bionix Development Corp. | 2010 | — |
| 0 (this device) | K122888 | CDR Systems Precision Patient Positioning System | Cdr Systems, Inc. | 2013 | — |
| +1 | K153026 | Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body… | Medtec, Inc. D/B/A Civco Medical Solutions | 2016 | — |
| +2 | K210894 | Siddharth-II; Impact | Panacea Medical Technologies Pvt., Ltd. | 2021 | — |
| +3 | K222762 | Siddharth-II;Impact | Panacea Medical Technologies Pvt., Ltd. | 2023 | — |
| +1 | K182079 | Solstice SRS Immobilization System; Solstat Immobilization System; Solstice… | Medtec Inc. Dba Civco Medical Solutions | 2018 | 1 |
| +2 | K171133 | Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and… | Qfix | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 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 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K100691 | Omni V SBRT Positioning System, Model RT-4500Summary page 1…ation Therapy System, 9OLHN, (per 21 CFR section 892.5050) Predicates: Bionix Development Corporation K100691: Omni V SBRT Positioning System K050701: Thigh and Foot Positioner, SuProne Plus… | 2010 |
| * | K050701 | Thigh and Foot Positioner, Suprone Plus, Model RT-6010Summary page 1…section 892.5050) Predicates: Bionix Development Corporation K100691: Omni V SBRT Positioning System K050701: Thigh and Foot Positioner, SuProne Plus K040773: Pelvis BellyBoard Plus Patient Positioning… | 2005 |
| * | K040773 | Pelvis Bellyboard Plus Patient Positioning SystemSummary page 1…on K100691: Omni V SBRT Positioning System K050701: Thigh and Foot Positioner, SuProne Plus K040773: Pelvis BellyBoard Plus Patient Positioning System, SecureFoam System, SecureFit Bar… | 2004 |
| * | K030051 | Versaboard, Model 7040Summary page 1…K040773: Pelvis BellyBoard Plus Patient Positioning System, SecureFoam System, SecureFit Bar K030051: Versaboard Patient Positioning System Civco Medical Solutions K1 11340: MR… | 2003 |
| * | K111340 | Head and Neck Immobilization System, Body Immobilization SystemSummary page 1…stem, SecureFit Bar K030051: Versaboard Patient Positioning System Civco Medical Solutions K1 11340: MR Patient Positioning Devices Device Description: The CDR Systems Precision Patient Positioning System consists of several op… | 2011 |
What descends from it? (5)
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 19 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 33 ancestors have a recall of any class.
- Of its descendants, K153026 (Medtec, Inc. D/B/A Civco Medical Solutions, 2016) has gone furthest, with 3 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
CDR Systems Precision Patient Positioning System is indicated to assist in the proper positioning of patients for radiation therapy and radiosurgery simulation and treatment including electron, photon and proton treatments. Place a clean sheet over the device to ensure a clean device from patient to patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122888 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122888: CDR Systems Precision Patient Positioning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122888
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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