FDA.report

CinemaVision

Primary DI
B867RTC55000
Brand
CinemaVision
Company
RESONANCE TECHNOLOGY, INC.
Model
RTC550
Device description
Audio/Video MRI Patient comfort device
Published
2020-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LHNSystem, Radiation Therapy, Charged-Particle, Medical

Product Code Classifications

CodeDeviceSpecialtyClass
LHNSystem, Radiation Therapy, Charged-Particle, MedicalRadiology2

Premarket Submissions

SubmissionSupplement
K994351000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K994351000M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEMResonance Technology, Inc.2000-03-22LNH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B867RTC55000PrimaryHIBCC0

GMDN Terms

TermDefinition
Patient audiovisual communication/entertainment systemAn assembly of devices intended to be used to provide a communication and/or entertainment channel for a patient undergoing a radiological examination (e.g., MRI scan). It typically consists of a control unit, intercom, and data communication hub; with earplugs, or other personal audio device, and/or a visual monitor for the patient. It may be supplied in a modular fashion.

Sterilization Methods

Method

Contacts

PhoneEmail
8188821997ben@mrvideo.com

Regulatory Flags

DUNS number
622142123
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices Sharing Product Codes

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00866854000401X-ray Imaging System (XIS)EhmetDx LLCLHN2025-03-21
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04560333350204PROBEATHITACHI, LTD.LHN2024-01-19
04560333350211PROBEATHITACHI, LTD.LHN2023-12-20
04560333350228PROBEATHITACHI, LTD.LHN2023-12-20
00858991006088ProBeam 360 Proton Therapy System - Rotating GantryVarian Medical Systems Particle Therapy GmbHLHN2023-10-25
04560333350198PROBEATHITACHI, LTD.LHN2023-10-02
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B237ZXLAOT160Zephyr Patient Positioning and Transfer SystemDiacor, Inc.LHN2023-06-08
00858991006071ProBeam 360 Proton Therapy System - Rotaiting GantryVarian Medical Systems Particle Therapy GmbHLHN2022-12-06
03760290230156SDX SystemDYN'RLHN2022-03-04
B237ZXLADK050Zephyr Patient Positioning and Transfer SystemDIACOR, INC.LHN2021-12-22
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B237ZXLADK500Zephyr Patient Positioning and Transfer SystemDIACOR, INC.LHN2021-12-22
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B237ZXLAOT100Zephyr Patient Positioning and Transfer SystemDIACOR, INC.LHN2021-12-22
B237ZXLAOT110Zephyr Patient Positioning and Transfer SystemDIACOR, INC.LHN2021-12-22
B237ZXLAOT120Zephyr Patient Positioning and Transfer SystemDIACOR, INC.LHN2021-12-22
B237ZXLAOT130Zephyr Patient Positioning and Transfer SystemDIACOR, INC.LHN2021-12-22
B237ZXLAOT140Zephyr Patient Positioning and Transfer SystemDIACOR, INC.LHN2021-12-22
B237ZXLAOT150Zephyr Patient Positioning and Transfer SystemDIACOR, INC.LHN2021-12-22
B237ZXLASB010Zephyr Patient Positioning and Transfer SystemDIACOR, INC.LHN2021-12-22