PANORAMA 1.0T

K041602 · Philips Medical Systems North America, Inc. · LNH · Jul 26, 2004 · Radiology

Device Facts

• Record ID: K041602
• Device Name: PANORAMA 1.0T
• Applicant: Philips Medical Systems North America, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jul 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

PANORAMA 1.0T is a Magnetic Resonance Diagnostic Device intended for general diagnostic use that produces transverse, sagittal, coronal and oblique crosssectional images based upon H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

Device Story

PANORAMA 1.0T is a magnetic resonance diagnostic device (MRDD) featuring a vertical field, superconducting actively shielded 1.0 Tesla magnet, and a dockable wheeled patient table. It acquires H metabolite signals to generate cross-sectional images (transverse, sagittal, coronal, oblique) of internal body structures. Operated by trained clinical staff in a diagnostic imaging environment, the device provides images for interpretation by a physician to assist in clinical diagnosis. It functions as a platform-based evolution of the INTERA ACHIEVA system, maintaining similar safety and effectiveness profiles while offering vertical field imaging capabilities.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and performance standards (NEMA, FDA MR Guidance, UL, IEC 601).

Technological Characteristics

Superconducting actively shielded magnet; 1.0 Tesla static field; vertical field configuration; dockable wheeled patient table. Complies with NEMA voluntary standards, FDA MR Diagnostic Device Guidance, UL, and IEC 601 safety standards.

Indications for Use

Indicated for general diagnostic imaging of the whole body in patients requiring transverse, sagittal, coronal, or oblique cross-sectional images based on H metabolites. For use by trained physicians. 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

• INTERA ACHIEVA (K031815)

Submission Summary (Full Text)

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XJR-148-6269/bf

KOHINOOR

# JUL 2 6 2004

Page 1 of 2

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The following information is being submitted in accordance with the requirements of 21 CFR 807.92.

#### General information

| Company Name | : | Philips Medical Systems Nederland BV |
|-----------------------|---|------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | : | Veenpluis 4-6<br>Best, Netherlands, 5684 PC |
| Registration No. | : | 1217116 |
| Contact person | : | Joseph S. Arnaudo.<br>Sr., Regulatory Manager<br>Tel: [phone]<br>Fax: [phone]<br>Joseph S. [e-mail] |
| Device (Trade) Name | : | PANORAMA 1.0T. |
| Classification Name | : | Magnetic Resonance Diagnostic Device (MRDD). |
| Classification | : | Class II. |
| Product code | : | LNH |
| Performance standards | : | NEMA voluntary standards, FDA MR Diagnostic<br>Device Guidance, UL and IEC 601 appropriate safety<br>standards and/or draft standards are used |

#### Predicate Device(s):

The PANORAMA 1.0T is a magnetic resonance diagnostic device with a vertical field based on the same platform as its predicate device cylindrical INTERA ACHIEVA (ref. K031815).

#### Indications for use:

PANORAMA 1.0T is a Magnetic Resonance Diagnostic Device intended for general diagnostic use that produces transverse, sagittal, coronal and oblique crosssectional images based upon H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

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#### Device description:

The PANORAMA 1.0T provides the same functionalities as its predicate device. It is a magnetic resonance diagnostic device with a vertical field. It uses a super conducting actively shielded magnet with a static field of 1.0 Tesla and a dockable wheeled patient table (couch).

## General Safety and Effectiveness.

The PANORAMA 1.0T does not induce any other risks than already indicated for the predicate devices. It has the same safety and effectiveness as its predicate device.

### Substantial Equivalence.

It is the opinion of Philips Medical Systems that the PANORAMA 1.0T is substantially equivalent to its predicate device.

End

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three wavy lines representing the three levels of health services: direct care, environmental health, and preventive medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 6 2004

Mr. Joseph S. Arnaudo Senior Regulatory Manager Philips Medical Systems North America 22100 Bothell Everett Highway BOTHELL WA 98021

Re: K041602

Trade/Device Name: PANORAMA 1.0T Regulatory Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II

Product Code: 90 LNH Dated: June 9, 2004 Received: June 14, 2004

Dear Mr. Arnaudo:

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 probibitions 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. Brygdon

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

Enclosure

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Page 1 of 1.

K041602 510(k) Number (if known):

Device Name :

PANORAMA 1.0T.

Indication For Use :

PANORAMA 1.0T is a Magnetic Resonance Diagnostic Device intended for general diagnostic use that produces transverse, sagittal, coronal and oblique crosssectional images based upon 'H metabolites, and that displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

Prescription Use _ X (Per 21 CFR 801.109) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

## ( PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon
(Division Sign Off)

(Optional Format 1-2-96)

(Division Sign Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number 1041602