MAGNETOM C! MR SYSTEM

K041111 · Siemens Medical Solutions USA, Inc. · LNH · Jul 16, 2004 · Radiology

Device Facts

• Record ID: K041111
• Device Name: MAGNETOM C! MR SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jul 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MAGNETOM C! is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM C! may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles

Device Story

MAGNETOM C! is an open, whole-body magnetic resonance imaging (MRI) scanner. It acquires magnetic resonance signals to produce transverse, sagittal, coronal, and oblique cross-sectional images and spectroscopic data. Operated by trained clinicians in a clinical setting, the device assists in diagnosing conditions by displaying internal anatomy and function. It supports interventional procedures when used with MR-compatible accessories like biopsy needles and in-room displays. The system transforms raw MR signals into diagnostic-quality images for physician interpretation, aiding clinical decision-making through high-resolution visualization of patient anatomy.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was validated against FDA-recognized NEMA standards for MR diagnostic devices, including measurements of signal-to-noise ratio, image uniformity, geometric distortion, slice profile, and high-contrast spatial resolution.

Technological Characteristics

Open, whole-body MRI scanner. Operates as a magnetic resonance diagnostic device (MRDD). Conforms to NEMA standards for performance and IEC standards for safety. Technical parameters include static magnetic field, RF power deposition, and acoustic noise management. Connectivity and software architecture details are not specified beyond standard MR system operation.

Indications for Use

Indicated for patients requiring diagnostic MR imaging of the head, body, or extremities to visualize internal structure and function. Used for diagnostic imaging and interventional procedures (e.g., biopsies) using MR-compatible devices. Prescription use only.

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

• Siemens MAGNETOM 0.2 T Concerto (K003192)
• Siemens MAGNETOM 1.0 T Harmony (K970852)

Submission Summary (Full Text)

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K0411111

# Section 2: 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.

I. General Information

| Establishment | Siemens Medical Solutions. Inc.<br>51 Valley Stream Parkway<br>Malvern. PA 19355 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 2240869 |
| Manufacturer | Siemens Mindit Magnetic Resonance Ltd.<br>R1-B1, Hi-Tech Industrial Park, Shennan Ave.<br>Shenzhen 518057<br>P.R. China |
| Registration Number | Application is Progress (See Attachment 3) |
| Contact Person | Ms. Nealie Hartman<br>Technical Specialist. Regulatory Submissions<br>51 Valley Stream Parkway E50<br>Malvern. PA 19355<br>Phone: [phone]<br>Fax: [phone] |
| Device Name | Trade Name: MAGNETOM C! System<br>Classification Name: Magnetic Resonance Diagnostic Device<br>CFR Code: 21 CFR § 892.1000<br>Classification: Class II |

#### Performance Standards

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

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## II. Safety and Effectiveness Information Supporting Substantial Equivalence.

### Intended Use

The MAGNETOM C! is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM C! may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles

#### Device Description

The MAGNETOM C! system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times.

#### Substantial Equivalence

The system is substantially equivalent to the following cleared medical devices:

| Predicate Device Name | FDA Clearance<br>Number | FDA Clearance<br>Date |
|---------------------------------|-------------------------|-----------------------|
| Siemens MAGNETOM 0.2 T Concerto | K003192 | 12/21/2000 |
| Siemens MAGNETOM 1.0 T Harmony | K970852 | 06/05/1997 |

### General Safety and Effectiveness Concerns:

Operation of the MAGNETOM C! System is substantially equivalent to the commercially available MAGNETOM 0.2 T Concerto System and 1.0 T Harmony System. Specified by the FDA guidance document for MR Diagnostic Devices that will be evaluated, below are the safety parameter with the following levels:

Action Levels

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

Performance Levels

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

The MAGNETOM C! will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM Concerto and Harmony systems.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 6 2004

Ms. Nealie Hartman Technical Specialist Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway MALVERN PA 19355

Re: K041111

Trade/Device Name: MAGNETOM C! Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device

Regulatory Class: II Product Code: 90 LNH Dated: April 26 , 2004 Received: April 28, 2004

Dear Ms. Hartman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Bugden

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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# SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known) ___ K 0 4 1/ 1/

Device Name: MAGNETOM C!

Indications for Use:

The MAGNETOM C! is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, (WITDB) and irroges and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM C! may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles

(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 | |
|------------------|---|----|----------------------|--|
|------------------|---|----|----------------------|--|

Nancy C Bugdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K041111 |
|---------------|---------|
|---------------|---------|

CONFIDENTIAL