(76 days)
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No
The document describes hardware and software enhancements to an existing NMR (MRI) system, focusing on subsystems, imaging sequences, and acquisition/reconstruction techniques. There is no mention of AI, ML, deep learning, or any related concepts in the provided text. The description of the operating software explicitly states that the basic features are unchanged.
No
The device aids in diagnosis by producing images for interpretation by a physician, but it does not directly treat or provide therapy.
Yes
The system produces images that, when interpreted by a trained physician, "yield information that can be useful in the determination of a diagnosis," directly indicating its role in the diagnostic process.
No
The device description explicitly states that the enhancement package includes changes to multiple hardware subsystems (computer, magnet, gradient, RF, patient handling, magnet enclosure, power distribution) in addition to software changes (imaging sequences, acquisition/reconstruction techniques). This indicates it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an NMR device that produces images. These images are then interpreted by a trained physician to yield information useful in diagnosis. This describes an in vivo imaging device, not an in vitro diagnostic device.
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device does not interact with or analyze such specimens.
- Device Description: The description focuses on the components of an MRI system (magnet, gradients, RF, etc.) and imaging sequences, which are characteristic of an in vivo imaging modality.
Therefore, based on the provided text, this device falls under the category of a medical imaging device used for in vivo diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The system enhancement package does not change the existing indications for the standard Outlook system as defined below.
The Outlook system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Product codes
LNH
Device Description
The Outlook System Enhancement Package includes changes in the computer subsystem, magnet subsystem, gradient subsystem, RF subsystem, patient handling subsystem, magnet enclosure and the power distribution subsystem. The package also includes additional imaging sequences and acquisition/reconstruction techniques. However, the basic features of the operating software are unchanged.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Magnetic Resonance (MR) Imaging System
Anatomical Site
head and whole body
Indicated Patient Age Range
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Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
K97 4844
MAR 1 0 1998
SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)
General Information 1.
Classification:
Class II Magnetic Resonance (MR) Imaging System
Common/Usual Name:
Magnetic Resonance (MR) Imaging Option
Proprietary Name:
Outlook System Enhancement Package
Establishment Registration:
Manufacturer: Picker Nordstar, Inc. P.O. Box 33 FIN-00511 Helsinki, Finland +358-9-394 127 Phone: +358-9-146 2811 Fax. FDA Facility Registration #9680194
United States Representative: Picker International, Inc. World Headquarters 595 Miner Road Highland Heights, Ohio 44143 FDA Owner Number: #1580240
Performance Standards:
No applicable performance standards have been issued under section 514 of the Food, Drug and Cosmetic Act.
2. Intended Uses
The system enhancement package does not change the existing indications for the standard Outlook system as defined below.
The Outlook system is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
1
Device Description 3.
The Outlook System Enhancement Package includes changes in the computer subsystem, magnet subsystem, gradient subsystem, RF subsystem, patient handling subsystem, magnet enclosure and the power distribution subsystem. The package also includes additional imaging sequences and acquisition/reconstruction techniques. However, the basic features of the operating software are unchanged.
Safety and Effectiveness 4.
Outlook systems with the System Enhancement Package are similar in technological characteristics and intended use to the standard Outlook system and the EDGE/VISTA System Enhancement Package. The following chart has been created to demonstrate their substantial equivalence.
| Item | Outlook System Enhancement
Package | Predicate Devices
Standard Outlook (K945827)
Edge/Vista System
Enhancement (K964626) |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Computer subsystem | Same display/database computer
system with some additional
options.
Ethernet communication system
Scan/reconstruction hardware:
• single processor for
reconstruction
• additional hard disk for buffering
image raw data
DICOM 3.0 compliant | Display/database computer system:
• workstation
• single monitor
• movable keyboard and mouse
• magnetic disk storage
• optical disk storage
• CD-ROM
Ethernet communication system
Scan/reconstruction hardware:
• 16 parallel processors for
reconstruction
(See K945827)
DICOM 3.0 compliant. (See
K964626) |
| Magnet subsystem | • Iron C-arm magnet
• Ramp up time: 6 minutes
• Increased stability of magnetic
field | • Iron C-arm magnet
• Ramp up time: 10 minutes
(See K945827) |
| Item | Outlook System Enhancement
Package | Predicate Devices
Standard Outlook (K945827)
Edge/Vista System
Enhancement (K964626) |
| Gradient subsystem | Increased gradient performance
with an active shielded design. | Gradient performance level of 12
mT/m and 20 T/m/s with a
shielded design. (See K945827) |
| RF subsystem
• RF amplifier max
average power | • 500 W | • 250 W |
| • Receive bandwidth | • ± 100 kHz | • ± 50 kHz
(See K945827) |
| Patient Handling
subsystem | • Modified couch movable in two
directions | • Couch movable in two directions |
| | • Laser positioning | • Laser positioning
(See K945827) |
| Magnet Enclosure | Fiberglass enclosure re-designed to
accommodate patient handling
subsystem. | Fiberglass enclosure.
(See K945827) |
| Power Distribution
subsystem | Same with the addition of line
voltage monitoring circuitry. | Isolation transformer, transient
suppression circuitry, power
distribution center all contained in
a single cabinet. (See K945827) |
| Operating software | Same. | Windows NT based Graphical
User Interface and scan /
reconstruction software with
multi-tasking capability.
(See K945827) |
| Imaging Sequences | Same with enhancements to
Inversion Recovery and Fast Spin
Echo sequences. | Standard: Field Echo, Spin Echo,
Inversion Recovery, Dual Echo,
and CBASS. |
| | | Optional: Fast Spin Echo and
Angiography. (See K945827) |
| Item | Outlook System Enhancement
Package | Predicate Devices
Standard Outlook (K945827)
Edge/Vista System
Enhancement (K964626) |
| Acquisition and
Reconstruction
Techniques | Same with addition of:
• Read Conjugate Symmetry
• TrueRes
• Keyhole | Main features include:
• Presaturation
• MAST
• Optimized Data Acquisition
• Phase Conjugate Symmetry
• No Phase Wrap-Around
• No Slice Wrap-Around
• Dynamic Imaging
• Cardiac gating
• Optimized Bandwidth
• Turbo Multislice
(See K945827) |
| Receive Only Coils | • Head
• Brain
• Vascular Head and Neck
• Neck
• Body/Spine
• Flexible Spine
• Multipurpose
• Extremity
• Small Joints | • Head
• Vascular Head and Neck
• Neck
• Body
• Spine
• Flexible Spine
• Multipurpose
• Extremity
(See K945827) |
| Static Magnetic
Field | Same. | 0.23 T (See K945827) |
| Time Varying
Magnetic Field | Same. | Normal operating mode:
$dB/dt \le 40$ T/s
First level controlled operating
mode:
$dB/dt \le 60$ T/s
(See K964626) |
| Radiofrequency
Absorption | Same. | Normal operating mode: Limited
to a maximum level of 1.2 W/kg.
First level controlled operating
mode: Limited to a maximum
level of 3.2 W/kg. (See K964626) |
| Acoustic Noise | Same. | A-weighted average value