(89 days)
Not Found
No
The summary describes a mechanical positioning device for an MRI scanner and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is intended for diagnostic purposes, specifically to produce images for the determination of a diagnosis, and to evaluate anatomy and functional interactions, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section states that the images produced by the NMR device, when interpreted by a trained physician, "yield information that can be useful in the determination of a diagnosis." This clearly indicates its role in the diagnostic process.
No
The device description clearly details physical positioning devices for the cervical spine, knee, and shoulder, which are hardware components used in conjunction with an NMR/MR imaging system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Picker International Outlook system and its Kinematic Positioning Devices are described as an NMR (Nuclear Magnetic Resonance) device that produces images of the body. The positioning devices are used to constrain body parts during imaging.
- Intended Use: The intended use is to produce images that provide information useful in determining a diagnosis when interpreted by a trained physician. This is a function of an imaging system, not an in vitro test.
- No Mention of Samples: The description does not mention the analysis of any samples taken from the body.
Therefore, the device falls under the category of a medical imaging system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Picker International Outlook system is intended for use as a NMR device that produces images that: ( ) ) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, 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.
The Kinematic Positioning Devices enable the physician to evaluate the anatomy and the functional interactions of the surrounding tissues (ligaments, cartilage, bone, muscle and fat). The Kinematic Positioning Devices are indicated for use in the Cervical Spine, Knee and Shoulder.
Product codes
Not Found
Device Description
The Outlook C-spine positioning device is designed to keep the head of the patient constrained in different positions while the C-spine is being imaged in the Outlook scanner. The device allows flexion, extension, lateral movement and lateral rotation. There is also a possibility to set the distance between the horizontal (flexion/extension) axis and the vertical axis (lateral motion). The device has an integrated holder for the Multipurpose receiver coil.
The Outlook Knee positioning device is designed to keep the leg constrained in different positions while the knee joint is imaged in the Outlook system with a Multipurpose coil. The device is used for flexion and extension of the knee.
The Outlook Knee positioning device is designed to keep the arm of the patient constrained in different positions while the shoulder joint is being imaged in the Outlook scanner. The device allows abduction, adduction and internal/external rotation. The device has an integrated holder for the Multipurpose receiver coil.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR) Imaging System
Anatomical Site
Cervical Spine, Knee, Shoulder, head and whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
FEB 2 4 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
(As required by 21 CFR 807.92)
General Information ਜਾਂ
| K964752 | |
|---|---|
| Classification: | Class II |
| Magnetic Resonance (MR) Imaging System | |
| Common/Usual Name: | Magnetic Resonance Imaging Accessories |
| Proprietary Name: | Kinematic Positioning Devices: C-Spine, Knee and |
| Shoulder |
Establishment Registration
| Manufacturer: | Picker Nordstar, Inc.
P.O. Box 33
FIN-00511 Helsinki, FINLAND
Phone: +358-9-394 127
Fax: +358-9-146 2811
FDA Facility Registration #9680194 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| United States
Representative: | Picker International, Inc.
595 Miner Road
Cleveland, OH 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 Picker International Outlook system is intended for use as a NMR device that produces images that: ( ) ) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, 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.
The Kinematic Positioning Devices enable the physician to evaluate the anatomy and the functional interactions of the surrounding tissues (ligaments, cartilage, bone, muscle and fat). The Kinematic Positioning Devices are indicated for use in the Cervical Spine, Knee and Shoulder.
2/19/97 】- I PICKER INTERNATIONAL, INC. (KINE)
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こした **************************************************************************************************************************************************************************
C-Spine Positioning Device
the state the state of the state of the states of the same
The Outlook C-spine positioning device is designed to keep the head of the patient constrained in different positions while the C-spine is being imaged in the Outlook scanner. The device allows flexion, extension, lateral movement and lateral rotation. There is also a possibility to set the distance between the horizontal (flexion/extension) axis and the vertical axis (lateral motion). The device has an integrated holder for the Multipurpose receiver coil.
Knee Positioning Device
The Outlook Knee positioning device is designed to keep the leg constrained in different positions while the knee joint is imaged in the Outlook system with a Multipurpose coil. The device is used for flexion and extension of the knee.
Shoulder Positioning Device
The Outlook Knee positioning device is designed to keep the arm of the patient constrained in different positions while the shoulder joint is being imaged in the Outlook scanner. The device allows abduction, adduction and internal/external rotation. The device has an integrated holder for the Multipurpose receiver coil.
4. Safety and Effectiveness
The Picker International Kinematic Positioning Devices for the Outlook are similar in technological characteristics and intended use to the Siemen's Kinematic Knee Device for the Magnetom Open System (K961121). The following chart has been created to demonstrate their substantial equivalence.
(KINE)
2/19/97
I - 2
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2
| Parameter | Kinematic Positioning Devices
for the Outlook | Predicate Device
Kinematic Knee Device for the
Magnetom Open System
(K961121) |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material | Same | No ferromagnetic materials
which could affect the scan field. |
| Device operation | Same | Manually operated by the user.
No active components such as
motors. |
| Indications for Use | C-Spine, Knee, Shoulder
scanning | Knee scanning |
| Intended use | The Siemens Magnetom Open is a magnetic resonance imaging
system which uses time-varying magnetic field gradients and rf
energy to spatially encode the anatomy of the patient. The kinematic
knee device will enable the physician to evaluate the anatomy of the
knee and dynamic interaction of the different tissues (ligaments,
cartilage, bone, muscle, fat). | The Picker International Outlook system is intended for use as a
NMR device that produces images that: (1) correspond to the
distribution of protons exhibiting NMR, (2) depend upon NMR
parameters (proton density, flow velocity, spin-lattice relaxation time
T1, 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.
The Kinematic Positioning Devices enable the physician to evaluate
the anatomy and the functional interactions of the surrounding tissues
(ligaments, cartilage, bone, muscle and fat) |
SUBSTANTIAL EQUIVALENCE CHART
PICKER INTERNATIONAL, INC.
(KINE)
2/19/97
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