510(k) Report

FDA applicant

Viewray, Incorporated

Oakwood Village, OH6 decisions2011–202112 recalls

FDA records 6 decisions for Viewray, Incorporated (Oakwood Village, OH) from 2011 to 2021: 6 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and MUJ (System, Planning, Radiation Therapy Treatment). Since 2016 its 510(k)s took a median of 136 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 6 of them its own earlier devices. 12 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Viewray, Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2011: 12012: 12017: 22019: 12021: 1
2011high 2 (2017) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2021

2015: 52016: 12019: 32020: 22021: 1
2011high 5 (2015) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Viewray, Incorporated by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Viewray, Incorporated’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • IYEAccelerator, Linear, Medical5decisions
  • MUJSystem, Planning, Radiation Therapy Treatment1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 136 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K170751MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated · 20173cite it
  • K162393The ViewRay (MRIdian) Linac SystemViewray, Incorporated · 20172cite it
  • K102915Viewray Treatment Planning and Delivery SystemViewray, Incorporated · 20112cite it
  • K111862Viewray SystemViewray, Incorporated · 20121cites it
  • K181989MRIdian Linac SystemViewray, Incorporated · 20191cites it

What has FDA decided for it lately?

  • K212958MRIdian Linac SystemViewray, Incorporated · 2021
  • K181989MRIdian Linac SystemViewray, Incorporated · 20192 recalls
  • K170751MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated · 20174 recalls
  • K162393The ViewRay (MRIdian) Linac SystemViewray, Incorporated · 2017
  • K111862Viewray SystemViewray, Incorporated · 20129 recalls
  • K102915Viewray Treatment Planning and Delivery SystemViewray, Incorporated · 20111 recall

All 6 as Viewray, Incorporated →

What has been recalled?

12 recalls linked to its devices; the latest:

  • K181989ViewRay MRIdian Linac System: Model No. 20000-01 software, CE 0086 - Product Usage…May 4, 2021Class II
  • K111862ViewRay MRIdian System: Model No. 10000, CE, Rated Supply Voltage - 380/480 VAC, 3 -…Oct 20, 2020Class II
  • K170751ViewRay MRIdian Linac System: Model No. 20000, CE, Rated Supply Voltage - 380/480 VAC, 3…Oct 20, 2020Class II
  • K111862ViewRay System: Model No. 10000 and 20000 for radiation treatment. PN11440 MRIdian…Nov 18, 2019Class II
  • K170751MRIdian Linac Radiation Therapy System, Model 20000.Mar 18, 2019Class II
  • K111862MRIdian Linac Radiation Therapy System Model 10000 and 20000Mar 3, 2019Class II