510(k) · Cleared
Recalled · Class II · 2021RefleXion Medical Radiotherapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reflexion Medical, Inc. · IYE Accelerator, Linear, Medical
Cleared on Mar 12, 2020 as substantially equivalent to K121934 (Accuray Incorporated, 2012) after a 332-day review. Its family tree reaches back 11 generations to 1992. It has been recalled once.
- Decided
- Mar 12, 2020
- Review
- 332 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 11 generations to K914698 (1992). 27 ancestors in all, the oldest K882729 (1988). No later device cites it as a predicate yet.
- Root · 11 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 7 generations between
- 3 generations backK082005 Modification to HI-Art Treatment SystemTomotherapy Incorporated · 2008 · Recalled
- 2 generations backK112776 Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated · 2011
- 1 generation backK121934 Tomotherapy Treatment SystemAccuray Incorporated · 2012 · Recalled
- This deviceK190978 RefleXion Medical Radiotherapy SystemReflexion Medical, Inc. · 2020
Show all 11 generations
- Root · 11 generations backK914698 Setup Computer with Software V-1261,62 and 63K.S., Inc. · 1992
- 10 generations backK980904 Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc. · 1998
- 9 generations backK990833 Dose Calc, Model VS. 1.02Integrity Medical Software, Inc. · 1999
- 8 generations backK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
- 7 generations backK013673 HI-Art SystemTomo Therapy, Inc. · 2002
- 6 generations backK033347 Modification to: HI-Art SystemTomotherapy Incorporated · 2003
- 5 generations backK042739 HI-Art SystemTomotherapy Incorporated · 2004
- 4 generations backK060912 Modification to: HI-Art SystemTomotherapy Incorporated · 2006 · Recalled
- 3 generations backK082005 Modification to HI-Art Treatment SystemTomotherapy Incorporated · 2008 · Recalled
- 2 generations backK112776 Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated · 2011
- 1 generation backK121934 Tomotherapy Treatment SystemAccuray Incorporated · 2012 · Recalled
- This deviceK190978 RefleXion Medical Radiotherapy SystemReflexion Medical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K914698 | Setup Computer with Software V-1261,62 and 63 | K.S., Inc. | 1992 | — |
| −10 | K980904 | Mucheck Monitor Unit Validation Program | Medical Dosimetry Services, Inc. | 1998 | — |
| −9 | K990833 | Dose Calc, Model VS. 1.02 | Integrity Medical Software, Inc. | 1999 | — |
| −8 | K993923 | Adac PINNACLE3TM Radiation Therapy Planning System | Adac Laboratories | 2000 | — |
| −7 | K013673 | HI-Art System | Tomo Therapy, Inc. | 2002 | — |
| −6 | K033347 | Modification to: HI-Art System | Tomotherapy Incorporated | 2003 | — |
| −5 | K042739 | HI-Art System | Tomotherapy Incorporated | 2004 | — |
| −4 | K060912 | Modification to: HI-Art System | Tomotherapy Incorporated | 2006 | 4 |
| −3 | K082005 | Modification to HI-Art Treatment System | Tomotherapy Incorporated | 2008 | 7 |
| −2 | K112776 | Tomotherapy Treatment System Fast Optimizer | Tomotherapy Incorporated | 2011 | — |
| −1 | K121934 | Tomotherapy Treatment System | Accuray Incorporated | 2012 | 8 |
| 0 (this device) | K190978 | RefleXion Medical Radiotherapy System | Reflexion Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 4 | 0 |
| 2001 | 2 | 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 |
|---|---|---|---|
| * | K121934 | Tomotherapy Treatment SystemSummary page 4…Regulatory Class: Class II Product Code IYE (radiation therapy), MUJ (planning) PREDICATE DEVICE TomoTherapy Treatment System (K121934) DEVICE DESCRIPTION The RefleXion Medical Radiotherapy System (RMRS), a hybrid imaging-therapy system, is capable of deliverin… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 24, 2021 | Class II | Z-0470-2022 | Software design | Due to dose discrepancy when delivering a plan to a patient in a Non-HFS (Head First Supine) orientation specifically in Feet First Supine (FFS). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 7 of the 27 ancestors have a recall of any class.
- 4 other devices also cite its predicate K121934.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The RefleXion Medical Radiotherapy System is indicated for treatment planning and precise delivery of image-guided radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery for tumors or other targeted tissues anywhere in the body when radiation treatment is indicated, while minimizing the delivery of radiation to vital healthy tissue. The megavoltage X-ray radiation is delivered in a rotational, modulated, image-guided format in accordance with the physician approved plan.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190978 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190978: RefleXion Medical Radiotherapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190978
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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