The SIEMENS MAGNETOM Project 047 is a 1.5 Tesla whole body magnetic resor:ance imaging (MRI) system intended for general diagnostic use. This MRI system will present images which reflect the spatial distribution and/or magnetic resonance spectra which are a function of the 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.

Device Description

The SIEMENS MAGNETOM Project 047 is a 1.5T whole body magnetic resonance imaging (MRI) system. The MAGNETOM Project 047 is the second member of a family of magnetic resonance imaging (MRI) systems. The MAGNETOM Project 047 system is a high field strength system. The new MAGNETOM system has a new compact design and a redesigned patient table and rf coil system.

AI/ML Overview

This submission is for a 1.5T whole body magnetic resonance imaging (MRI) system, the SIEMENS MAGNETOM Project 047. The primary claim for safety and effectiveness is based on substantial equivalence to previously cleared devices (SIEMENS MAGNETOM Vision and MAGNETOM Impact systems), rather than a study demonstrating specific performance against acceptance criteria for a new clinical indication.

Therefore, the following information is not applicable or not provided in the submitted document:

Acceptance Criteria and Reported Device Performance Table: No such table is presented as the device is not undergoing a new performance validation against specific criteria.
Sample Size and Data Provenance for Test Set: No specific test set or clinical study data is provided to demonstrate the device's performance against acceptance criteria. The claim is based on the equivalency of technological characteristics.
Number of Experts and Qualifications for Ground Truth: Not applicable, as there's no clinical performance study requiring expert ground truth.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable, as no human reader studies are mentioned.
Standalone (Algorithm Only) Performance Study: Not applicable, as this is a hardware and software system, not an AI algorithm being evaluated in isolation.
Type of Ground Truth Used: Not applicable.
Sample Size for Training Set: Not applicable, as no specific AI model or training set is mentioned in the context of performance validation.
How Ground Truth for Training Set was Established: Not applicable.

Summary of the provided information regarding acceptance criteria and study:

The submission focuses on establishing substantial equivalence to existing, legally marketed MRI systems (MAGNETOM Vision and MAGNETOM Impact).

The "study" in this context is a comparison of technological characteristics and safety features.

Acceptance Criteria (Implied by Substantial Equivalence):

The device must be a 1.5T whole-body MRI system.
Its technological characteristics (e.g., compact design, redesigned patient table, rf coil system) must be similar to or provide equivalent safety and effectiveness as the predicate devices.
It must have the same intended use: whole-body magnetic resonance imaging for general diagnostic use.
It must produce images reflecting spatial distribution and/or magnetic resonance spectra, and other physical parameters derived from these, including hydrogen-1 (proton) imaging.
It must not raise additional safety concerns compared to the predicate devices.

Reported Device Performance (Implied by Substantial Equivalence):

The device is a 1.5T whole body MRI system.
It is considered to have safety and performance characteristics within the scope of parameters cleared for market for the MAGNETOM Vision and MAGNETOM Impact systems.
No additional safety concerns have been raised.
The device labeling will contain appropriate instructions, indications, precautions, cautions, contraindications, and warnings.

The Study Proving Equivalence:

The "study" is outlined under "II. Safety and Effectiveness Information Supporting Substantial Equivalence."

Device Description: The SIEMENS MAGNETOM Project 047 is described as a 1.5T whole-body MRI system, and the second member of a family of MRI systems.
Intended Use: "Whole body magnetic resonance imaging."
Technological Characteristics: The MAGNETOM Project 047 is described as a "high field strength system" with a "new compact design and a redesigned patient table and rf coil system."
General Safety and Effectiveness Concerns: The key statement is that "The safety and performance characteristics for this system are within the scope of parameters cleared for market for the MAGNETOM Vision and MAGNETOM Impact systems. No additional safety concerns have been raised."
Substantial Equivalence: The conclusion is explicitly stated: "The MAGNETOM Project 047 system is substantially equivalent to the SIEMENS MAGNETOM Vision and MAGNETOM Impact magnetic resonance imaging systems."

The FDA's letter (K971684) confirms this determination, stating that the device is "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This FDA letter is the official "proof" of the device meeting the substantial equivalence criteria.

Summary

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AUG - 5 1991

ﻣﺴﺴﺴﺴﺴ

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.
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Establishment:
• Address:	Siemens Medical Systems, Inc.
	186 Wood Avenue South
	Iselin, N.J. 08830
Registration Number:	2240869
Contact Person:	Ms. Kathleen Rutherford
	Manager, Regulatory Submissions
	(908) 321-4779
	(908) 321-4841
Date of Summary Preparation:	4/18/97
Device Name:
• Trade Name:	MAGNETOM Project 047
• Classification Name:	Magnetic Resonance Diagnostic Device,
	CFR § 892.1000
• Classification:	Class II
• Performance Standards:	None established under Section 514 ofthe Food, Drug, and Cosmetic Act.

II. Safety and Effectiveness Information Supporting Substantial Equivalence.

Device Description:

The SIEMENS MAGNETOM Project 047 is a 1.5T whole body magnetic resonance imaging (MRI) system. The MAGNETOM Project 047 is the second member of a family of magnetic resonance imaging (MRI) systems.

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SIEMENS

Intended Use:

Whole body magnetic resonance imaging.

Technological Characteristics:

The MAGNETOM Project 047 system is a high field strength system. The new MAGNETOM system has a new compact design and a redesigned patient table and rf coil system.

General Safety and Effectiveness Concerns:

The safety and performance characteristics for this system are within the scope of parameters cleared for market for the MAGNETOM Vision and MAGNETOM Impact systems. No additional safety concerns have been raised.

The device labeling for the Project 047 system will contain instructions for use, indications for use, precautions, cautions, contraindications, and warnings to the user.

Substantial Equivalence:

The MAGNETOM Project 047 system is substantially equivalent to the SIEMENS MAGNETOM Vision and MAGNETOM Impact magnetic resonance imaging systems.

Kathleen Rutherford

Kathleen M. Rutherford Manager, Regulatory Submissions Imaging Systems Group Siemens Medical Systems, Inc.

5/6/92

Date

MAGNETOM Project 047 / Numaris 3.5 Software

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Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized lines that resemble a human form or a stylized caduceus. The text "SERVICES USA" is located at the top of the seal.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kathleen Rutherford Manager, Regulatory Submission Siemens Medical Systems, Inc. . . 186 Wood Avenue South Iselin, N.J. 08830

Re: K971684 MAGNETOM Project 047 Dated: May 6; 1997 ... ... .. Received: May 7, 1997 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH

AUG - 5 1997

Dear Ms. Rutherford:

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 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, 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 III (Premarket Approval), it may be ;abject : ... 1 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 requirement, 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 notification 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 yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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/dsmamain.html".

Sincerely vours.

h7liau Yri
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K9] 1684______

Device Name: MAGNETOM Project 047

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use__

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Over-The-Counter Use__

Ra-a. Ruy

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number .

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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.