(58 days)
No
The summary describes a simple input/output device (monitor and mouse) for controlling existing system functions, with no mention of AI/ML terms, image processing, or performance studies typically associated with AI/ML devices.
No
The device is described as an operating console with a monitor and mouse, intended to control and monitor main system functions within an RF-cabin. Its purpose is to facilitate conventional procedures, not to directly treat or diagnose a medical condition.
No
The device description indicates that the In-Room MRC facilitates conventional procedures and allows the operator to control and monitor system functions. It is described as a local monitor and mouse for controlling an MR console, with no mention of analyzing or interpreting medical images or patient data to make a diagnosis. Its function is operational control of an MR system, not diagnostic interpretation.
No
The device description explicitly mentions hardware components (local monitor, mouse) that are part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate conventional procedures" and allow the operator to "control and monitor main system functions inside the RF-cabin." This describes a device used during a medical procedure (specifically, likely an MRI procedure given the "Magnetic Resonance" input modality and "RF-cabin" setting), not a device used to test samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a monitor and mouse used for controlling and monitoring an MR system. This aligns with a control interface for a medical imaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with IVD devices.
Therefore, this device is a component of a medical imaging system (specifically, an MRI system) used for controlling and monitoring the system during a procedure, not an IVD.
N/A
Intended Use / Indications for Use
The new In-Room MRC is intended to facilitate conventional procedures. The new operating console allows the system operator to control and monitor main system functions inside the RF-cabin.
Product codes
Not Found
Device Description
The In-Room MRC consists of a local monitor and mouse. The local monitor is a liquid crystal display (LCD) with the same image resolution as the standard diagnostic console. The scan-room-mouse is positioned alongside the magnet and controls the functions of the local monitor. It is similar to the conventional track ball-mouse used at the standard MR console and is fully compatible with the software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
system operator / inside the RF-cabin
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
Not Found
Key Metrics
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
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SEP 2 5 1996
Appendix 8:
510(k) Summary
1
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| I. General Information. | |
|---|---|
| Establishment: | |
| • Address: | Siemens Medical Systems, Inc. |
| 186 Wood Avenue South | |
| Iselin, N.J. 08830 | |
| Registration Number: | 2240869 |
| Contact Person: | Cathy Anne Pinto |
| Sr. Technical Specialist, Regulatory Affairs | |
| (908) 321-4887 | |
| (908) 321-4841 | |
| Date of Summary Preparation: | July 26, 1996 |
| Device Name: | |
| • Trade Name: | In-Room MRC/ |
| MAGNETOM VISION and IMPACT | |
| • Classification Name: | Magnetic Resonance Diagnostic Device, |
| CFR § 892.1000 | |
| • Classification: | Class II |
| • Performance Standards: | None established under Section 514 of |
| the Food, Drug, and Cosmetic Act. |
II. Safety and Effectiveness Information Supporting Substantial Equivalence.
Device Description:
The In-Room MRC consists of a local monitor and mouse. The local monitor is a liquid crystal display (LCD) with the same image resolution as the standard diagnostic console. The scan-room-mouse is positioned alongside the magnet and controls the functions of the local monitor. It is similar to the conventional track ball-mouse used at the standard MR console and is fully compatible with the software.
Intended Use:
The new In-Room MRC is intended to facilitate conventional procedures. The new operating console allows the system operator to control and monitor main system functions inside the RF-cabin.
07/26/96
510(k)
2
SIEMENS
Technological Characteristics:
The local monitor and mouse serve the same function as the standard MR console except that, patient registration must be performed from the standard MR console in the control room via the keyboard.
General Safety and Effectiveness Concerns:
Operation of the new In-Room MRC does not affect any of the MR safety and performance parameters, including:
[safety]
- static field strength, -
- RF exposure, -
- time varying magnetic fields -
- acoustic noise levels -
[performance]
- signal-to-noise, -
- high contrast spatial resolution,
- slice thickness,
- image uniformity and,
- geometric distortion.
In addition, all new components have been designed and tested for MR compatibility with the system. There is no electrodynamical interference with the static magnetic field, the magnetic field gradients, or the rf system. Consequently, there is no influence on image quality or system performance.
Substantial Equivalence:
The In-Room MRC for the VISION and the IMPACT is substantially equivalent to In-Room MRC commercially available for the MAGNETOM OPEN system.
Kathleen Rutherford
Kathleen M. Rutherford Manager, Regulatory Submissions Imaging Systems Group Siemens Medical Systems, Inc.
7/26/96
Date