(88 days)
Not Found
No
The description focuses on a software feature that reduces acquisition time by manipulating phase encodings, which is a standard MR imaging technique, not indicative of AI/ML. There are no mentions of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML devices.
No
Explanation: The PCS Option is a software feature designed to reduce acquisition time for MR imaging without impacting resolution. It does not exert any therapeutic effect on the patient. Its function is to optimize the imaging process, not to treat or mitigate a disease.
No
The device is described as a software feature that reduces MR acquisition time without impacting resolution, indicating it's an image acquisition aid rather than a diagnostic tool itself. Its indications for use are the same as standard MR imaging, which is used for diagnosis, but this device specifically aids in the acquisition of those images, not their interpretation for diagnostic purposes.
Yes
The device is described as a "software feature" that modifies the acquisition process of an existing MR Imaging System. It does not mention any new hardware components being introduced.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce acquisition time in standard MR Imaging. This is a function related to the imaging process itself, not the analysis of biological samples in vitro.
- Device Description: The device is described as a software feature that modifies the MR imaging acquisition process.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are specifically designed for testing samples taken from the human body.
The device is a software option for an MR Imaging system, which is an in vivo imaging modality.
N/A
Intended Use / Indications for Use
The Phase Conjugate Symmetry (PCS) Option reduces the acquistion time by approximately 40% without impacting the resolution. The indications for use are the same as for standard MR Imaging.
Product codes
Not Found
Device Description
The Phase Conjugate Symmetry (PCS) Option is a software feature which reduces the acquistion time by reducing the number of phase encodings needed to create an image.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR) Imaging System
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
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).(b)
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.
0
K 960294
(
APR 1 9 1996
ATTACHMENT I
Summary of Safety and Effectiveness
1
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 acquistion 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 acquistion time by reducing the
number of phase encodings needed to
create an image. |
Safety and Effectiveness 4.
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
2
Image /page/2/Picture/0 description: The image shows a sequence of handwritten characters. The characters appear to be 'K960294'. The characters are written in a dark ink, and the background is white. The handwriting is somewhat stylized, with distinct shapes for each character.
| 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. |
| Acquisition 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 |
feature introduced by Picker International in the DVP Software Option 510(k) submission (K895151).
(1/19/96)