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MRIdian A3i Software

FDA UDI

Class II (US FDA UDI)

by Viewray Incorporated

Identity

Trade Name
MRIdian A3i Software FDA UDI
Generic Name
Linear accelerator system FDA UDI
Model / Reference
A3i FDA UDI

Identifiers

Primary DI / UDI-DI
00850036816027 FDA UDI
510(k) Number
K212958 FDA UDI
FDA Product Code
IYE FDA UDI
LNH FDA UDI
GMDN Term
Linear accelerator system 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

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

MRIdian A3i Software 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 75751bdf-d1b0-4376-8c6a-1dba6db675c0 33 fields · synced May 29, 2026