VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM— 510(k) K102915

Name: FDA 510(k) clearance K102915
Creator: U.S. Food and Drug Administration
Published: 2011-01-12

Substantially Equivalent

Viewray, Incorporated

FDA 510(k) clearance K102915 for VIEWRAY TREATMENT PLANNING AND DELIVERY SYSTEM, Substantially Equivalent on 2011-01-12. Applicant: Viewray, Incorporated. Device class: 2.

Clearance details

Applicant: Viewray, Incorporated
Product code: Code MUJ
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2010-10-01
Decision date: 2011-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakwood Village, OH, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K102915

K-number listed on FDA's recall record

Z-1836-2021 — ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage: intended to be used for planning external beam irradiation with photon beams and delivering stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated, in conjunction with the ViewRay System, an MRI image-guided radiation therapy system.Class II·Terminated·Viewray, Inc.·20210504

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102915.

Data sourced from openFDA. This site is unofficial and independent of the FDA.