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MRIdian Linac System

FDA UDI

Class II (US FDA UDI)

by Viewray Incorporated

Identity

Trade Name
MRIdian Linac System FDA UDI
Generic Name
Stereotactic teletherapy radionuclide system, MRI-imaging FDA UDI
Model / Reference
20000-01 FDA UDI

Identifiers

Primary DI / UDI-DI
00868029000346 FDA UDI
510(k) Number
K212958 FDA UDI
FDA Product Code
IYE FDA UDI
LNH FDA UDI
GMDN Term
Stereotactic teletherapy radionuclide system, MRI-imaging FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 FDA UDI
892.1000 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Linear accelerator systemStereotactic teletherapy radionuclide system, MRI-imaging

MRIdian Linac System by Viewray Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stereotactic teletherapy radionuclide system, MRI-imaging.

Cleared under the same submission

K212958 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Viewray Incorporated

Sources (1)

  • FDA UDI 6b00966f-f2ef-44dc-af0b-9c2c68ae4cba 33 fields · synced Jun 8, 2026