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MRIview

FDA UDI

Class II (US FDA UDI)

by Mriaudio

Identity

Trade Name
MRIview FDA UDI
Generic Name
Patient audiovisual communication/entertainment system FDA UDI
Device Name
The MRIview is an MRI conditional video solution that provides MRI patients with visual entertainment. FDA UDI
Model / Reference
3000 FDA UDI
Description
The MRIview is an MRI conditional video solution that provides MRI patients with visual entertainment. FDA UDI

Identifiers

Catalog Number
3000 FDA UDI
Primary DI / UDI-DI
B66930001 FDA UDI
510(k) Number
K193102 FDA UDI
FDA Product Code
LNH FDA UDI
GMDN Term
Patient audiovisual communication/entertainment system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
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 Conditional FDA UDI

Category: Patient audiovisual communication/entertainment system

MRIview by Mriaudio — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient audiovisual communication/entertainment system.

Cleared under the same submission

K193102 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mriaudio

Sources (1)

  • FDA UDI 59b998bf-f346-4ad3-ad9a-e65a7e2a177a 36 fields · synced May 30, 2026