510(k) · Cleared
ClearedQfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qfix · IYE Accelerator, Linear, Medical
Cleared on Jul 11, 2017 as substantially equivalent to K153026 (Medtec, Inc. D/B/A Civco Medical Solutions, 2016) after an 85-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Jul 11, 2017
- Review
- 85 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K935300 (1994). 35 ancestors in all, the oldest K854886 (1986). No later device cites it as a predicate yet.
- Root · 7 generations backK935300 Vac-Lok Immobilization SystemMedtec, Inc. · 1994
- 6 generations backK960338 Stereotactic Body FrameElekta Instrument AB · 1996
- 5 generations backK970291 Accessories to the Stereotactic Body FramElekta Instrument AB · 1997
- 4 generations backK991336 Bodyloc Whole Body Stereotactic Localizer System for RadiotherapyMedical Instrumentation & Diagnostics Corp.(Midco) · 1999
- 3 generations backK100691 Omni V SBRT Positioning System, Model RT-4500Bionix Development Corp. · 2010
- 2 generations backK122888 CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013
- 1 generation backK153026 Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body…Medtec, Inc. D/B/A Civco Medical Solutions · 2016
- This deviceK171133 Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution…Qfix · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K935300 | Vac-Lok Immobilization System | Medtec, Inc. | 1994 | — |
| −6 | K960338 | Stereotactic Body Frame | Elekta Instrument AB | 1996 | — |
| −5 | K970291 | Accessories to the Stereotactic Body Fram | Elekta Instrument AB | 1997 | — |
| −4 | K991336 | Bodyloc Whole Body Stereotactic Localizer System for Radiotherapy | Medical Instrumentation & Diagnostics Corp.(Midco) | 1999 | — |
| −3 | K100691 | Omni V SBRT Positioning System, Model RT-4500 | Bionix Development Corp. | 2010 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K153026 | Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt…Summary page 6…umber and Date code MEDTEC, Inc. Body Pro-Lok™ Respiratory K153026, cleared d/b/a CIVCO Plate with Cushion, Body Pro- IYE… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 35 ancestors have a recall of any class.
- 1 other device also cites its predicate K153026.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Device-Specific Intended Use: The Qfix® Abdominal/Thoracic Motion Control System is intended to apply abdominal compression for managing internal body motion during respiration while maintaining maximum comfort to the patient. The Qfix® Abdominal/Thoracic Motion Control System is also intended to promote shallow breathing in radiation therapy or radiology. System Intended Use: The Qfix® Abdominal/Thoracic Motion Control System can be used as part of the…
Read the full statement (94 words)
Device-Specific Intended Use: The Qfix® Abdominal/Thoracic Motion Control System is intended to apply abdominal compression for managing internal body motion during respiration while maintaining maximum comfort to the patient. The Qfix® Abdominal/Thoracic Motion Control System is also intended to promote shallow breathing in radiation therapy or radiology.
System Intended Use: The Qfix® Abdominal/Thoracic Motion Control System can be used as part of the Qfix® SBRT Solution and Accessories including, Qfix’s kVue™, Stradivarius™, VacQFix™ and DoseMax™ inserts, overlays, and standalone devices which are intended to immobilize, position and reposition patients undergoing radiation therapy including SBRT.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171133 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171133: Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171133
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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