(90 days)
Not Found
No
The summary describes a system for providing audio and visual entertainment and communication in an MRI environment, focusing on hardware components and basic functionalities like noise reduction and video display. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
No
The device is intended to improve patient comfort and reduce fear during MRI scans by providing audio and visual entertainment, not to treat or diagnose a disease or condition.
No.
The device's stated intended use is to provide audio and visual to patients to improve comfort and eliminate fear during an MRI, not to diagnose medical conditions. It serves as an accessory to the MRI environment.
No
The device description explicitly details hardware components such as glasses, audio transducer, noise canceling headset, and microphone.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to improve patient comfort and reduce fear during MRI procedures by providing audio and visual entertainment and communication. This is a supportive function within a medical imaging procedure, not a diagnostic test performed on samples from the human body.
- Device Description: The device is an audio-visual system designed for patient comfort and communication within the MRI environment. It does not involve analyzing biological samples or providing diagnostic information about a patient's health condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly an accessory to the MRI system, focused on the patient experience during the imaging process.
N/A
Intended Use / Indications for Use
The M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System is indicated for use as an accessory to the MRI environment to provide audio and visual to patients and thus improve patient comfort and aid in eliminating fear associated with MRI use.
Product codes
LNH
Device Description
The system consists of a pair of glasses coupled with an audio transducer and noise canceling headset. The headset decreases gradient noise by up to 30 dB and includes a microphone that permits two way communication between the technologist and the patient. The video option provides an illusion of viewing a 60" screen and can be viewed in 3D. Television can be viewed with 180,000 pixels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
MRI environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study conducted by UCLS Dept of Neurology concludes M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System is MRI Compatible and MRI Safe.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Attachment I 510(K) Summary Resonance Technology, Inc M.R. Vision 2000 Ultra audio visual system
This 510(K) Summary of safety and effectiveness for the Resonance Technology, Inc M.R. Vision 2000 Ultra audio visual system is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Resonance Technology, Inc. |
|---|---|
| Address: | 18121 Parthenia Street |
| Northridge, CA 91325 | |
| Contact Person: | Mokhtar Ziarati |
| President | |
| Telephone: | (818) 882-1997 - Phone |
| (818) 882-5524 - Fax | |
| Preparation Date: | December 12, 1999 |
| Device Trade Name: | M.R.Vision 2000 Ultra |
| Common Name: | |
| Classification Name: | Accessory to MRI |
| System, Nuclear Magnetic Resonance Imaging | |
| Product Code: LNH | |
| Legally Marketed Predicate Device: | Avocet Silent Scan |
| K number K921891 | |
| Description of the M.R. Vision 2000 Ultra | |
| Audio Visual System / Commander X6 | |
| System | The system consists of a pair of glasses coupled with an |
| audio transducer and noise canceling headset. The headset | |
| decreases gradient noise by up to 30 dB and includes a | |
| microphone that permits two way communication between | |
| the technologist and the patient. | |
| The video option provides an illusion of viewing a 60" screen | |
| and can be viewed in 3D. Television can be viewed with | |
| 180,000 pixels. | |
| Intended use of the M.R. Vision 2000 | |
| Ultra Audio Visual System / Commander | |
| X6 System | The . M.R. Vision 2000 Ultra Audio Visual System / |
| Commander X6 System is intended for use in the MRI | |
| environment to provide audio and visual to patients and thus | |
| improve patient comfort and aid in eliminating fear | |
| associated with MRI use. | |
| Performance Data: | Study conducted by UCLS Dept of Neurology concludes |
| M.R. Vision 2000 Ultra Audio Visual System / Commander | |
| X6 System is MRI Compatible and MRI Safe. | |
| Conclusion: | The . M.R. Vision 2000 Ultra Audio Visual System / |
| Commander X6 System is substantially equivalent to other | |
| existing audio visual systems used in the MRI environment in | |
| commercial distribution. |
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 2 2000
Mokhtar Ziarati President Resonance Technology, Inc. 18121 Parthenia Street Northridge, CA 91325
Re:
K994351 M.R. Vision 2000 Ultra Audio Visual System/ Commander X6 System Dated: December 20, 1999 Received: December 23, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Ziarati:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual recistration, listing of devices, good manufacturing and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notfication submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-5597 or at its internet address "http://www.fda.gov/odrh/dsmaldsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
2
INDICATION FOR USE STATEMENT
Pending K 994 351 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System
Indications for Use:
The M.R. Vision 2000 Ultra Audio Visual System / Commander X6 System is indicated for use as an accessory to the MRI environment to provide audio and visual to patients and thus improve patient comfort and aid in eliminating fear associated with MRI use.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_V (per 21 CFR 801.109)
ー
OR
Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT
and Radiological Devices
510(k) Number K994351