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

Oakwood Village, OH, US

VIEWRAY SYSTEMS, INC. appears in FDA device records in Oakwood Village, OH. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
6
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Viewray Systems, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Viewray, Incorporated510(k), enforcement report, recall

510(k) clearance history

FDA records hold 6 510(k) clearances for Viewray Systems, Inc. between 2011 and 2021. The busiest year on record is 2017, with 2. The most recent is 2021, with 1.

Clearances by year, as a table
510(k) clearance decisions for Viewray Systems, Inc., by decision year
YearClearances
20111
20121
20172
20191
20211
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K212958MRIdian Linac SystemIYESubstantially Equivalent
K181989MRIdian Linac SystemIYESubstantially Equivalent
K170751MRIdian Linac System with 138-leaf CollimatorIYESubstantially Equivalent
K162393The ViewRay (MRIdian) Linac SystemIYESubstantially Equivalent
K111862VIEWRAY SYSTEMIYESubstantially Equivalent
K102915VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEMMUJSubstantially Equivalent

Registered establishments

FDA registered establishments for Viewray Systems, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30075465343007546534VIEWRAY SYSTEMS, INC.2 Thermo Fisher Way, Oakwood Village, OH 44146 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-1309-2016MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicatedWhen editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the potential to deliver dose to the initial isocenter rather than the new location.Class IITerminated
Z-0806-2016MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.The system loaded a completion fraction in the incorrect order after a treatment interruption.Class IITerminated
Z-0115-2016MRIdian ViewRay Radiation Therapy System, ViewRay Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly.Class IITerminated
Z-1954-2015Treatment Planning and Delivery System Software version 3.6. ViewRay. Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.The software was failing to determine new patient locations if imaging is not enabled during treatment.Class IITerminated
Z-2085-2015Patient Handling System (Motion Control Software), Product Usage: Indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot.Class IITerminated
Z-1580-2015ViewRay System, Radiation Therapy SystemThe software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error.Class IITerminated

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