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CinemaVision

FDA UDI

Class II (US FDA UDI)

by Resonance Technology, Inc.

Identity

Trade Name
CinemaVision FDA UDI
Generic Name
Patient audiovisual communication/entertainment system FDA UDI
Device Name
Audio/Video MRI Patient comfort device FDA UDI
Model / Reference
RTC550 FDA UDI
Description
Audio/Video MRI Patient comfort device FDA UDI

Identifiers

Primary DI / UDI-DI
B867RTC55000 FDA UDI
510(k) Number
K994351 FDA UDI
FDA Product Code
LHN FDA UDI
GMDN Term
Patient audiovisual communication/entertainment system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5050 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

No

FDA UDI

Category: Patient audiovisual communication/entertainment system

CinemaVision by Resonance Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient audiovisual communication/entertainment system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Resonance Technology, Inc.

Sources (1)

  • FDA UDI c3719781-2fa3-483e-ad52-ccee4e19cde9 35 fields · synced May 30, 2026