Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or any related technologies in the intended use, device description, or performance studies. The focus is on the hardware capabilities (higher gradient amplitudes) and standard MRI principles.

Therapeutic

No
The device is described as a "diagnostic imaging device" used to "produce images" that "provide information that can be useful in determining a diagnosis," not for treating conditions.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "The MAGNETOM SYMPHONY with the High End Gradients is indicated for use as diagnostic imaging device..." and mentions that the images provide information useful "in determining a diagnosis."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "whole body scanner" and mentions "higher gradient amplitudes," which are hardware components of an MRI system.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the device is a "diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body." It produces images based on the magnetic resonance properties of protons.
Mechanism: The device works by generating magnetic resonance images, which are then interpreted by a trained physician. This is a form of in vivo (within the living body) diagnostic imaging, not in vitro (outside the living body) testing of samples like blood, urine, or tissue.
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 specific analytes (proteins, genes, metabolites, etc.)
- Using reagents or assays

The device is a medical imaging system used to visualize internal structures of the body, which falls under the category of diagnostic imaging devices, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The MAGNETOM SYMPHONY with the High End Gradients is a whole body scanner with higher gradient amplitudes. The MAGNETOM SYMPHONY with the High End Gradients is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the MAGNETOM SYMPHONY with the High End Gradients reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin-spin relaxation time (T") and flow. When interpreted by a trained by a trained physician, these images provide information that can be useful in determining a diagnosis.

Product codes

LNH

Device Description

The MAGNETOM SYMPHONY with the High End Gradients is a whole body scanner with higher gradient amplitudes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Magnetic Resonance

Anatomical Site

head or body

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained physician

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

Laboratory testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.

Key Metrics

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

AUG = 3 1090

9/652

510 (k) Summary

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:

Siemens Medical Systems, Inc. . Address: 186 Wood Avenue South Iselin, N.J. 08830
Registration Number: 2240869
Mr. Jamie Yieh Contact Person: Technical Specialist, Regulatory Submissions (732) 321-4625 (732) 321-4841

5/12/99 Date of Summary Preparation:

Device Name:

High End Gradients • Trade Name:
Classification Name: Magnetic Resonance Diagnostic Device, CFR & 892.1000
Classification: Class II
· Performance Standards:

None established under Section 514 the Food, Drug, and Cosmetic Act.

1

II. Safety and Effectiveness Information Supporting Substantial Equivalence.

• Device Description:

· Intended Use

The MAGNETOM SYMPHONY with the High End Gradients is a whole body scanner with higher gradient amplitudes. The MAGNETOM SYMPHONY with the High End Gradients is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the MAGNETOM SYMPHONY with the High End Gradients reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin-spin relaxation time (T") and flow. When interpreted by a trained by a trained physician, these images provide information that can be useful in determining a diagnosis.

· Technological Characteristics

The MAGNETOM Symphony with the new High End Gradients is substantially equivalent to the MAGNETOM Symphony System.

· General Safety and Effectiveness Concerns:

Operation of the MAGNETOM Symphony with the new High End Gradients is substantially equivalent to the commercially available MAGNETOM Symphony System. The following safety parameters with action levels:

Maximum Static Field
. Rate of Change of Magnetic Field
. RF Power Deposition
. Acoustic Noise Levels

and performance levels

●

Specification Volume .
. Signal to Noise
. Image Uniformity
. Geometric Distortion
Slice Profile, Thickness and Gap •
. High Contrast Spatial Resolution

specified by the FDA guidance document for MR Diagnostic Devices were evaluated within this notification. The reduction in the minimum rise time of the system will affect both the acoustic noise levels and the rate of change of magnetic field strength (dB/dt), as well as certain performance levels with the system. However, the new levels are not significantly changed and, in the case of safety, parameters remain below the level of concern as outlined by the FDA Guidance.

2

• Substantial Equivalence:

Laboratory testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.

Kathleen Rutherford
Kathleen M. Rutherford

Manager, Regulatory Submissions

5/12/99
Date

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 1999

Jamie Yieh Technical Specialist, Regulatory Submissions Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, New Jersey 08830

RE:

K991652 High End Gradients for Magnetom Symphony Dated: May 12, 1999 Received: May 13, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Ms. Yieh:

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 prior 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 registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or 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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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) 594-4613. 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"(21 CFR 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) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

510(k) Number (if known)

High End Gradients for the MAGNETOM SYMPHONY Device Name: System

Indications for Use:

The MAGNETOM SYMPHONY with the High End Gradients is a whole body scanner with higher gradient amplitudes. The MAGNETOM SYMPHONY with the High End Gradients is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the MAGNETOM SYMPHONY with the High End Gradients reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin-spin relaxation time (T") and flow. When interpreted by a trained by a trained physician, these images provide information that can be useful in determining a diagnosis.

(please do not write below this line- continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation
Prescription Use	OR	Over-The-Counter Use
	(Division Sign-Off)
and Radiological Deyices
510(k) Number	Division of Reproductive, Abdominal, ENT,