510(k) · Cleared
ClearedRefleXion Medical Radiotherapy System, Reflexion X2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reflexion Medical, Inc. · QVA Fludeoxyglucose F18-Guided Radiation Therapy System
Cleared on Dec 18, 2025 as substantially equivalent to DEN220014 (Reflexion Medical, Inc., 2023) after a 170-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Dec 18, 2025
- Review
- 170 days
- Class
- Class II
- Product code
- QVA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN220014 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN220014 RefleXion Medical Radiotherapy System (RMRS)Reflexion Medical, Inc. · 2023
- This deviceK252071 RefleXion Medical Radiotherapy System, Reflexion X2Reflexion Medical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN220014 | RefleXion Medical Radiotherapy System (RMRS) | Reflexion Medical, Inc. | 2023 | — |
| 0 (this device) | K252071 | RefleXion Medical Radiotherapy System, Reflexion X2 | Reflexion Medical, Inc. | 2025 | — |
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 QVA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | DEN220014 | RefleXion Medical Radiotherapy System (RMRS)Summary page 5…Product Code: QVA Secondary Product code: IYE, MUJ Panel: Radiology Predicate Device Predicate Device Name: RefleXion Medical Radiotherapy System (RMRS) 510(k) Number: DEN220014 Manufacturer: RefleXion Medical, Inc. Reference Submission (if applicable): DEN220014 RefleXion Medical Inc.… | 2023 |
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?
- Its one ancestor has no recall.
How does its category compare?
All QVA devicesQVA Fludeoxyglucose F18-Guided Radiation Therapy System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QVA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QVA
Too few QVA 510(k)s in any year since 2007 to give a median.
Recalls per year · QVA
No recall names QVA since 2007.
Adverse event reports per year · QVA
9in 2025
MAUDE reports naming product code QVA, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
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…
Read the full statement (214 words)
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.
The RefleXion Medical Radiotherapy System is also indicated for FDG-guided treatment which includes modeling, planning and precise delivery of FDG-guided radiation therapy, a type of Biology-guided Radiotherapy (BgRT), in five or fewer fractions for adults. It is indicated for tumor volumes in lung and bone subject to potential motion and positional uncertainty that have each been assessed with on-board PET/CT prior to delivery for adequate localization, sufficient FDG metabolic activity, local contrast and consistent biodistribution to meet the RMRS requirements, while minimizing the delivery of radiation to vital healthy tissue. BgRT involves the detection of signals from F18 during active beam delivery as a guide to deliver megavoltage X-ray radiotherapy in a rotational, modulated format in accordance with a physician approved treatment plan.
For complete fludeoxyglucose F18 prescribing information, refer both to the current medical imaging agent labeling and to this device labeling under "FDG Medical Imaging Agent Information”.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252071 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252071: RefleXion Medical Radiotherapy System, Reflexion X2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252071
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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