VIEWRAY SYSTEM— 510(k) K111862
Substantially EquivalentViewray, Incorporated
FDA 510(k) clearance K111862 for VIEWRAY SYSTEM, Substantially Equivalent on 2012-05-22. 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 K111862
K-number listed on FDA's recall record- Z-0481-2021 — ViewRay MRIdian System: Model No. 10000, 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-0676-2020 — MRIdian Linac Radiation Therapy System Model 10000 and 20000
- Z-1309-2016 — MRIdian 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 indicated
- Z-0806-2016 — MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
- Z-0115-2016 — MRIdian¿ 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.
- Z-1954-2015 — Treatment 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.
- Z-2085-2015 — Patient 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.
- Z-1580-2015 — ViewRay System, Radiation Therapy System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111862.
Data sourced from openFDA. This site is unofficial and independent of the FDA.