Data / Medical devices / United States / Reflexion Medical, Inc.
Reflexion Medical, Inc.: FDA-registered device maker in Hayward, CA, United States, 3 510(k) clearances
Reflexion Medical, Inc. is registered with the FDA (registration 3011716550) in Hayward, CA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 18, 2025. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011716550
- Address
- 25881 Industrial Blvd, Hayward, CA, United States, 94545
- Owner or operator
- RefleXion Medical, Inc. (10078251)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 15, 2020
- Registered through
- 2027
- Brand names listed
- RXM1000, RefleXion Medical Radiotherapy System, RefleXion Medical Radiotherapy System, Reflexion X2, RefleXion Medical Radiotherapy System; Reflexion X1; RXM1000, Reflexion X1
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Fludeoxyglucose F18-Guided Radiation Therapy System | QVA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Planning, Radiation Therapy Treatment | MUJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 18, 2025 | K252071 | RefleXion Medical Radiotherapy System, Reflexion X2 | QVA | Substantially Equivalent | Reflexion Medical, Inc. | accessdata.fda.gov |
| February 1, 2023 | DEN220014 | RefleXion Medical Radiotherapy System (RMRS) | QVA | Unknown | Reflexion Medical, Inc. | accessdata.fda.gov |
| March 12, 2020 | K190978 | RefleXion Medical Radiotherapy System | IYE | Substantially Equivalent | Reflexion Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 9, 2026 | 98518 | Class II | Ongoing | RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 | Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, | accessdata.fda.gov |
| July 22, 2025 | 97311 | Class II | Ongoing | RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)2308 | Due to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could potentially lead to adverse events (toxicity). | accessdata.fda.gov |
| April 16, 2024 | 94533 | Class II | Ongoing | RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator. | A potential dose error exists for patients treated with an out of session SCINTIX partial fraction. | accessdata.fda.gov |
| November 24, 2021 | 89212 | Class II | Terminated | RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000" | 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). | accessdata.fda.gov |
Compare with other makers
- All makers of System, Planning, Radiation Therapy Treatment
- All makers of Accelerator, Linear, Medical
Updated March 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.