MAGNETOM VERIO

K072237 · Siemens Medical Solutions USA, Inc. · LNH · Oct 10, 2007 · Radiology

Device Facts

• Record ID: K072237
• Device Name: MAGNETOM VERIO
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LNH · Radiology
• Decision Date: Oct 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The MAGNETOM Verio is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and / or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The MAGNETOM Verio 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 Verio is a 3 Tesla superconducting MR scanner; utilizes Total Imaging Matrix (Tim) technology and Matrix Coils. Inputs include magnetic resonance signals from patient anatomy; system transforms signals into transverse, sagittal, coronal, and oblique cross-sectional images or spectra. Operated by trained clinicians in clinical settings; supports interventional procedures using MR-safe needles and in-room displays. Output images/spectra interpreted by physicians to assist in diagnosis. Benefits include high-field diagnostic imaging capabilities for head, body, and extremities.

Clinical Evidence

Bench testing only. Performance and safety data measured per NEMA, IEC, and ISO standards. Metrics included signal-to-noise ratio, geometric distortion, image uniformity, slice thickness, and spatial resolution. Performance compared directly to MAGNETOM Trio a Tim System to confirm equivalence.

Technological Characteristics

3 Tesla superconducting MR scanner; utilizes Total Imaging Matrix (Tim) technology and Matrix Coils. Software platform: syngo MR B15B (I-class and T-class releases). Conforms to NEMA, IEC, and ISO standards for MR safety (static field, acoustic noise, dB/dt, RF heating, biocompatibility).

Indications for Use

Indicated for patients requiring diagnostic imaging of head, body, or extremities via MRDD. Used for cross-sectional imaging, spectroscopic imaging, and interventional procedures with MR-compatible devices. Contraindications include patients incompatible with MR environments.

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 3T MAGNETOM Trio a Tim System (K050200)
• software syngo MR B15 (VB15A) (K062454)

Submission Summary (Full Text)

{0}------------------------------------------------

K072237

## Section 5: 510(k) Summary

# 5 510(k) Summary

001 1 0 2007

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 AG. Bereich Med<br>Henkestrasse 127<br>D-91052 Erlangen. Germany | |
| Registration Number | 8010024 | |
| Contact Person | Ms. Judy Campbell<br>Technical Specialist. Regulatory Submissions<br>51 Valley Stream Parkway<br>Malvern. PA 19355<br>Phone: [phone]<br>Fax: [phone] | |
| Device Name | Trade Name: MAGNETOM Verio | |
| | Classification Name:<br>CFR Code:<br>Classification: | Magnetic Resonance Diagnostic<br>Device<br>21 CFR § 892.1000<br>Class II |

#### Performance Standards

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

{1}------------------------------------------------

## Section 5: 510(k) Summary

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

### Intended Use

The MAGNETOM Verio is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and / or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM Verio 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 Verio comes with I-class and T-class releases based on syngo MR B15B. It is a 3 Tesla MR scanner based on a superconducting magnet. It consists of the same types of hardware (with a modified magnet, gradient coil and RF body coil) that are currently available with the MAGNETOM Trio a Tim system including Matrix Coils and Total Imaging Matrix (Tim) technology.

#### Substantial Equivalence

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

| Predicate Device Name | FDA Clearance<br>Number | FDA Clearance Date |
|------------------------------------------|-------------------------|--------------------|
| Siemens 3T MAGNETOM Trio a<br>Tim System | K050200 | Feb 28, 2005 |
| software syngo MR B15 (VB15A) | K062454 | Nov 3, 2006 |

{2}------------------------------------------------

#### General Safety and Effectiveness Concerns:

Operation of the MAGNETOM Verio is substantially equivalent to the commercially available MAGNETOM 3 T Trio a Tim System.

As specified in the FDA guidance document "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Devices" the following measurements of performance and safety data have been performed following National Electrical Manufacturing Association (NEMA) or equivalent IEC and ISO standards.

#### Safety

Static Field Strength Acoustic Noise dB/dt RF Heating Biocompatibility

#### Performance

Signal-to-Noise Ratio Geometric Distortion Image Uniformity Slice Thickness Spatial Resolution

The MAGNETOM Verio will conform to the measurement of safety parameters to the international IEC, ISO and NEMA standards for safety issues with Magnetic Resonance Imaging Diagnostic Devices.

Furthermore performance measurements have been done on MAGNETOM Verio and MAGNETOM Trio a Tim System to show that the performance of the MAGNETOM Verio is equivalent with respect to the predicate device MAGNETOM Trio a Tim System.

This will assure that the performance of MAGNETOM Verio is substantially equivalent with respect to the currently available MAGNETOM Trio a Tim System.

{3}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three wavy lines forming the body and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### 007 @ 2007

Ms. Judy Campbell Regulatory Technical Specialist Siemens Medical Solutions USA. Inc. Corporate Headquarters 51 Valley Stream Parkway MALVERN PA 19355

Re: K072237

Trade/Device Name: MAGNETOM Verio Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 8, 2007 Received: August 13, 2007

#### Dear Ms. Campbell:

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, 1796, 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.

{4}------------------------------------------------

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

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

Enclosure

{5}------------------------------------------------

# 4 Indications for Use Statement

510(k) Number (if known)

K072231

Device Name: MAGNETOM Verio

Indications for Use:

The MAGNETOM Verio is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM Verio 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

Division of Reproductive, Abdomina Radiological Devic 510(k) Number