PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK

K960294 · Philips Medical Systems (Cleveland), Inc. · LNH · Apr 19, 1996 · Radiology

Device Facts

• Record ID: K960294
• Device Name: PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: LNH · Radiology
• Decision Date: Apr 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Phase Conjugate Symmetry (PCS) Option reduces the acquisition time by approximately 40% without impacting the resolution. The indications for use are the same as for standard MR Imaging.

Device Story

Software feature for Outlook MRI system; reduces acquisition time by ~40% by decreasing required phase encodings; utilizes symmetry properties of Fourier transform to synthesize uncollected data; operator-selectable; used by MRI technicians/radiologists in clinical settings; output is reconstructed MR image; benefits patient via reduced scan time without resolution loss; safety parameters (static/time-varying magnetic fields, SAR, acoustic noise) remain unchanged from base system.

Clinical Evidence

Bench testing only; performance compared to predicate device (K895151) via technical parameters including acquisition time, SNR, and resolution. No clinical patient data provided.

Technological Characteristics

Software-based image reconstruction feature; utilizes Fourier transform symmetry properties to synthesize uncollected data; operates on Outlook MRI system; no changes to hardware, energy source, or safety specifications (static/time-varying magnetic fields, SAR, acoustic noise).

Indications for Use

Indicated for standard MR imaging applications; patient population consistent with general MRI diagnostic use.

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

• DVP Software Option (K895151)

Reference Devices

• Outlook system (K945827)

Submission Summary (Full Text)

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K 960294

K960294

APR 19 1996

# ATTACHMENT I

## Summary of Safety and Effectiveness

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K960294

# SUMMARY OF SAFETY AND EFFECTIVENESS

## 1. General Information

Classification: Class II
Magnetic Resonance (MR) Imaging System

Common/Usual Name: MRI System Option

Proprietary Name: Phase Conjugate Symmetry Option for Outlook

Establishment Registration: Picker Nordstar, Inc.
P.O. Box 33
FIN-00511 Helsinki, Finland
FDA Facility Registration #9680194

Performance Standards: Not applicable

## 2. Intended Uses

The Phase Conjugate Symmetry (PCS) Option reduces the acquisition time by approximately 40% without impacting the resolution. The indications for use are the same as for standard MR Imaging.

## 3. Device Description

The Phase Conjugate Symmetry (PCS) Option is a software feature which reduces the acquisition time by reducing the number of phase encodings needed to create an image.

## 4. Safety and Effectiveness

The safety specifications for static magnetic field, time varying magnetic field, SAR levels and acoustic noise established for the Outlook system (K945827) are unaffected by the Phase Conjugate Symmetry Option and therefore remain unchanged.

As shown in the chart below, the Phase Conjugate Symmetry Option for Outlook is identical with regards to image performance to the Phase Conjugate Symmetry

PICKER INTERNATIONAL, INC. (PCS) (1/19/96) I - 1

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K960294

feature introduced by Picker International in the DVP Software Option 510(k) submission (K895151).

| Parameter | Phase Conjugate Symmetry Option for Outlook | Predicate Device DVP Software (K895151) |
| --- | --- | --- |
| General Use | Operator selectable, can be used with all sequences with the exception of when the phase image option is chosen. | Operator selectable, can be used with any 2DFT and 3DFT sequence with the exception of read conjugate symmetry sequences. |
| Reconstruction Algorithm | Same as predicate. | Symmetry properties of the Fourier transform used to synthesize uncollected data. |
| Acquistion Time | Same as predicate. | Reduced as compared to a "normal" acquisition. |
| SNR | Same as predicate. | Reduce in a mathematically predictable manner. |
| Resolution | Same as predicate. | No Impact. |
| Intended Use | Same as MR | Same as MR |

PICKER INTERNATIONAL, INC. (PCS) (1/19/96)