MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)

K971684 · Siemens Medical Solutions USA, Inc. · LNH · Aug 5, 1997 · Radiology

Device Facts

• Record ID: K971684
• Device Name: MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Aug 5, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The SIEMENS MAGNETOM Project 047 is a 1.5 Tesla whole body magnetic resonance 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 Story

The MAGNETOM Project 047 is a 1.5T whole body MRI system. It acquires magnetic resonance signals to generate diagnostic images reflecting spatial distribution and magnetic resonance spectra of nuclei (specifically hydrogen-1). The system features a compact design, a redesigned patient table, and a new RF coil system. It is operated by trained clinical staff in a diagnostic imaging environment. The output consists of MR images and derived physical parameters, which are reviewed by physicians to assist in clinical diagnosis. The device benefits patients by providing non-invasive diagnostic imaging capabilities.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and safety/performance parameters consistent with previously cleared predicate devices.

Technological Characteristics

1.5T high field strength whole body MRI system. Features a compact design, redesigned patient table, and new RF coil system. Operates using magnetic resonance imaging principles. Software version: Numaris 3.5.

Indications for Use

Indicated for general diagnostic whole body magnetic resonance imaging (MRI) in patients requiring diagnostic imaging of spatial distribution and/or magnetic resonance spectra of nuclei exhibiting nuclear magnetic resonance, including hydrogen-1 (proton) imaging.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• MAGNETOM Vision
• MAGNETOM Impact

Submission Summary (Full Text)

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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. |
|--|-------------------------|
|--|-------------------------|

| 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 |
| | [phone] |
| | [phone] |
| 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 of<br>the 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 [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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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.

(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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