510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Reflexion Medical, Inc.

Hayward, CA, US

REFLEXION MEDICAL, INC. appears in FDA device records in Hayward, CA. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
3
PMA records
0
Recall records
4
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Reflexion Medical, Inc. between 2020 and 2025. The busiest year on record is 2020, with 1. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Reflexion Medical, Inc., by decision year
YearClearances
20201
20231
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252071RefleXion Medical Radiotherapy System, Reflexion X2QVASubstantially Equivalent
DEN220014RefleXion Medical Radiotherapy System (RMRS)QVAUnknown
K190978RefleXion Medical Radiotherapy SystemIYESubstantially Equivalent

Registered establishments

FDA registered establishments for Reflexion Medical, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30117165503011716550REFLEXION MEDICAL, INC.25881 Industrial Blvd, Hayward, CA 94545 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1656-2026RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00Due 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, with a 10% to 20% underdose.Class IIOpen, Classified
Z-2486-2025RefleXion 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)230811(21)X11006 (01)00860003983812(11)230410(21)X11007 (01)00860003983812(11)230803(21)X11008 (01)00860003983812(11)240528(21)X11009 (01)00860003983812(11)240820(21)X11010 (01)00860003983812(11)241107(21)X11011 (01)00860003983812(11)241206(21)X11012 The RefleXion X1 is a radiation therapy system that combines the functionality of an emission computed tomography detection system and a linear accelerator. The device is intended for use with approved fludeoxyglucose F18. The emission computed tomography detection system acquires images of positron-emitting fludeoxyglucose F18 for the purpose of guiding the delivery of megavoltage X-rays for oncologic treatment with radiation therapy using an FDA cleared, authorized, or approved linear accelerator.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).Class IIOpen, Classified
Z-1933-2024RefleXion 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.Class IIOpen, Classified
Z-0470-2022RefleXion 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).Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain