MRIdian Linac System with 138-leaf Collimator— 510(k) K170751
Substantially EquivalentViewray, Incorporated
FDA 510(k) clearance K170751 for MRIdian Linac System with 138-leaf Collimator, Substantially Equivalent on 2017-06-07. Applicant: Viewray, Incorporated. Device class: 2.
Clearance details
- Applicant
- Viewray, Incorporated
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oakwood Village, OH, US
Recent devices under product code IYE
view allMore clearances from Viewray, Incorporated
view allAdverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K170751
K-number listed on FDA's recall record- Z-0482-2021 — ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3 - Frequency Range (Hertz) - 50/60 Hz, Rated Input in Amperes - 210 A, UDI. The MRIdian system and the MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
- Z-1803-2020 — ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian System Treatment Planning and Delivery System (TPDS) software
- Z-1251-2019 — MRIdian Linac Radiation Therapy System, Model 20000.
- Z-0676-2020 — MRIdian Linac Radiation Therapy System Model 10000 and 20000
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K170751.
Data sourced from openFDA. This site is unofficial and independent of the FDA.