(89 days)
Not Found
No
The document describes a hardware package for an existing MRI system and does not mention any AI or ML capabilities in the device description, intended use, or other sections.
No.
The device is used for diagnostic imaging and guiding interventional procedures, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the images produced "yield information that can be useful in the determination of a diagnosis" and that the MRGP Basic Package supports "diagnostic interventional procedures."
No
The device description explicitly states that the MRGP Basic Package is an "optional hardware package" and lists several hardware components included in the package (foot pedal, kneeling pads, procedure light, coil, display).
No, 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. They are used to analyze these samples outside of the body.
- Device Function: The Outlook system and the MRGP Basic Package are used for imaging the human body using Magnetic Resonance Imaging (MRI). They produce images of internal structures.
- Intended Use: The intended use is to produce images that, when interpreted by a physician, can be useful in determining a diagnosis. This is a diagnostic tool, but it operates by imaging the body directly, not by analyzing samples taken from the body.
The device is a medical imaging device used for in-vivo (within the living body) diagnosis, not in-vitro diagnosis.
N/A
Intended Use / Indications for Use
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 (TI), 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.
The MRGP Basic Package is designed to support and guide diagnostic interventional procedures, such as needle biopsies and drainages.
Product codes
LHN
Device Description
The MRGP Basic Package is an optional hardware package for the Outlook and Outlook Proview systems. The package includes a foot pedal for starting scans from inside the scan room, kneeling pads for the physician, an MR compatible procedure light, a multipurpose coil with disposable protective coil coverings, and either an in-room LCD display or an in-room Large (36") Screen display. The package uses the standard software and sequences available with the Outlook and Outlook Proview systems.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
NMR
Magnetic Resonance Imaging (MRI)
Anatomical Site
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
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
1183342
DEC 2 1 1998
SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)
1. General Information
| Classification: | Class II
Magnetic Resonance Imaging (MRI) System | | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Common/Usual Name: | Magnetic Resonance Imaging (MRI) Option | | |
| Proprietary Name: | MR Guided Procedures (MRGP) Basic Package | | |
| Establishment Registration: | Manufacturer:
Picker Nordstar, Inc.
Ayritie 4, Vantaa
FIN-01510 Vantaa Finland
FDA Facility Registration: #9680194
United States Representative:
Picker International, Inc.
World Headquarters
595 Miner Road
Highland Heights, Ohio 44143
FDA Owner Number: #1580240
FDA Registration Number: #1525965 | | |
| Performance Standards: | No applicable performance standards have been
issued under section 514 of the Food, Drug and
Cosmetic Act. | | |
2. Intended Uses
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 (TI), 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.
The MRGP Basic Package is designed to support and guide diagnostic interventional procedures, such as needle biopsies and drainages.
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1
3. Device Description
The MRGP Basic Package is an optional hardware package for the Outlook and Outlook Proview systems. The package includes a foot pedal for starting scans from inside the scan room, kneeling pads for the physician, an MR compatible procedure light, a multipurpose coil with disposable protective coil coverings, and either an in-room LCD display or an in-room Large (36") Screen display. The package uses the standard software and sequences available with the Outlook and Outlook Proview systems.
Safety and Effectiveness 4.
The Picker MRGP Basic Package is substantially equivalent to the Siemens Magnetom Open MR Guided Procedures Package and the Picker Outlook System Enhancement Package. The following chart has been compiled to demonstrate this equivalence.
PICKER INTERNATIONAL, INC.
(MRGP)
2
Substantial Equivalence Chart
| Parameter | MR Guided Procedures
(MRGP) Basic Package | Outlook System Enhancement
Package (Proview) - K974844 | Siemens MR Guided Procedure
Package - K955389 |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| System Compatibility | 0.23T Outlook,
0.23T Outlook Proview | Not Applicable. | 0.2T Magnetom Open |
| Magnet Homogeneity | Same. | Same. | $\pm$ 5 ppm @ 40 cm DSV (FWHM) |
| Magnet ramp time | Same as K974844. | 6 minutes | Approx. 30 minutes |
| Gradient Design | Same as K974844. | Water-cooled gradient coils Peak strength - 16 mT/m Slew rate - 25 mT/m/ms | Water-cooled gradient coils Peak strength - 15 mT/m Slew rate -