(90 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware enhancements and performance improvements, not AI/ML capabilities.
No.
The device is used for producing images for diagnosis, not for therapy or treatment.
Yes
The device produces images that, when interpreted by a trained physician, "yield information that can be useful in the determination of a diagnosis." This explicitly states its role in the diagnostic process.
No
The device description explicitly mentions hardware components like a water-cooled gradient system and increased gradient performance, indicating it is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a NMR device that produces images of the human body (head and whole body). It is used to visualize soft tissue structure and provide information for diagnosis when interpreted by a trained physician.
- 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 Description: The description focuses on hardware enhancements to an existing MR system, which is an imaging modality, not a diagnostic test performed on biological samples.
- Input Modality: The input modality is NMR, which is an imaging technique, not a method for analyzing biological samples.
The ASSET APOLLO is an in vivo diagnostic imaging device, specifically an MRI system. It is used to visualize structures within the living body, not to analyze samples taken from the body.
N/A
Intended Use / Indications for Use
The Picker International ASSET 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 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 (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The ASSET APOLLO MR system includes the following enhancements: a water cooled gradient system, increased gradient performance, increased scan/reconstruction rates, and a user selectable bandwidth option.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
NMR
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
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K971884
AUG 2 0
SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)
| 1. | General Information
Classification: | Class II - Magnetic Resonance Imaging System |
|----|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Common/Usual Name: | Magnetic Resonance Imaging System |
| | Proprietary Name: | ASSET APOLLO |
| | Establishment Registration: | 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 ASSET APOLLO does not change the existing intended use for the ASSET system as defined below.
The Picker International ASSET 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 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.
3. Device Description
The ASSET APOLLO MR system includes the following enhancements: a water cooled gradient system, increased gradient performance, increased scan/reconstruction rates, and a user selectable bandwidth option.
4. Safety and Effectiveness
The ASSET APOLLO is similar in technological characteristics and intended use to the standard ASSET system and the EDGE/VISTA system enhancement package. The following chart has been created to demonstrate their substantial equivalence.
| PICKER INTERNATIONAL, INC. | (APOLLO) | 5/8/97 | I - 1 |
|---|---|---|---|
| ---------------------------- | ---------- | -------- | ------- |
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SUBSTANTIAL EQUIVALENCE CHART
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| ITEM | ASSET APOLLO | Predicate Device
ASSET (K933835) | Predicate Device
EDGE/VISTA with System
Enhancement Package
(K964626) |
|----------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Computer Subsystem | Same as K964626. | Display/Database computer and
scan reconstruction hardware
connected together by a dedicated
Ethernet communications system.
Allows for simultaneous scanning
and image
reconstruction/manipulation.
Single monitor for system
operation and image review.
Second Ethernet interface allows
for communication with systems
on the external network. | Display/database computer,
monitor and Ethernet
communications systems.
Ethernet communications link
complies with DICOM v3.0 to
allow image transfer to other MR,
CT, Nuclear, workstation systems
and cameras. Optional packages
available for increased image
reconstruction rates. |
| Image Storage
Short Term:
Archival: | Same.
Same. | Magnetic Disk
Optical Disk | Magnetic Disk
Optical Disk |
| ITEM | ASSET APOLLO | Predicate Device
ASSET (K933835) | Predicate Device
EDGE/VISTA with System
Enhancement Package
(K964626) |
| Gradient Subsystem
Gradient Coils: | Water-cooled self-shielded
gradient system. Phosphorous-
bronze RF screen. | Self-shield gradient coil designed
for Magnex 0.5T actively
shielded magnet. Copper RF
screen. | Water-cooled self-shielded
gradient system for all
performance levels. Stainless steel
RF screen. |
| Max. Gradient Strength | 16 mT/m | 10 mT/m | 16, 20 or 27 mT/m |
| Max. Slew Rate | 25 mT/m/msec | 18 mT/m/msec | 25, 40, 72 mT/m/msec |
| Gradient Amps: | 150 A RMS, 300 A peak, 400 V | Single high current drive
amplifier per axis. | 150 A RMS, 300 A peak, 400 V
or
270 A RMS, 440 A peak, 600 V |
| RF Subsystem | | | |
| DTR Spectrometer: | Same. | Single channel with fast sampling
ADC and additional digital
filtering. Three additional
receive channels are available as
an option. | Single Channel with fast sampling
ADC and additional digital
filtering. Three additional receive
channels are available as an
option. |
| RF Amplifiers: | Single frequency 5.0 kW RF
amplifier. | Single frequency 2.5 kW RF
amplifier. | Single frequency RF amplifiers. |
| Body Coil | Same as K933835. | 57 cm quadrature multi-
conductor transmit/receive. | 61 cm quadrature multi-conductor
transmit/receive coil. |
| ITEM | ASSET APOLLO | Predicate Device
ASSET (K933835) | Predicate Device
EDGE/VISTA with System
Enhancement Package
(K964626) |
| Head Coil | Same. | Quadrature multi-conductor
receive only. | Quadrature multi-conductor
receive only. |
| Receive Only Coil Connection | Same. | All receive only coils plug into
single couch RF connector. | All receive only coils plug into
single couch RF connector. |
| Transmit/Receive Box | Same. | Four receive channels in system.
(1 standard, 4 optional) | Four receive channels in system.
(1 standard, 4 optional) |
| Magnet Subsystem | Same as K933835. | Actively shielded magnet offered
at 0.5 T. | Active Shield Magnets offered at
1.5 T and 1.0 T. |
| Patient Handling | Same as K933835. | Horizontal motion only,
computer controlled patient
transport system. | Computer controlled patient
transport system with vertical and
horizontal motion. |
| Magnet Facade | Same. | Cylindrical fiberglass enclosure. | Cylindrical fiberglass enclosure. |
| Power Distribution Subsystem | Same. | Isolation transformer, transient
suppression circuitry, and power
distribution center all contained
in a single cabinet. | Isolation transformer, transient
suppression circuitry, and power
distribution center all contained in
a single cabinet. |
| ITEM | ASSET APOLLO | Predicate Device
ASSET (K933835) | Predicate Device
EDGE/VISTA with System
Enhancement Package
(K964626) |
| Operating Software | Same as K964626. | UNIX - X Windows based
operating software. Graphical
User Interface - windows and
Multi-tasking capability
provided. | UNIX - X Windows based
operating software. Graphical
User Interface - windows and
multi-tasking capability provided
|
| | | SCAN, VIEW, FILM, and
UTILITIES operations all
accessed from single console. | SCAN, VIEW, FILM and
UTILITIES operations all
accessed from single console.
|
| | | Able to switch between on-going
tasks. | Able to switch between on-going
tasks. |
| Operational Features | Same. | SCAN capabilities include: Pilot
positioning on three different
reference images. Preloaded
anatomical protocol categories. | SCAN capabilities include: Pilot
positioning on three different
reference images. Preloaded
anatomical protocol categories. |
| | | VIEW capabilities include:
Multiplanar reconstruction and
curvilinear reformatting. | VIEW capabilities include: Multi
planar reconstruction and
curvilinear reformatting.
|
| | | FILM capabilities include: ability
to set film formats and load print
queue directly from
Display/Database computer. | FILM capabilities include: ability
to set film formats and load print
queue directly from
Display/Database computer. |
| ITEM | ASSET APOLLO | Predicate Device
ASSET (K933835) | Predicate Device
EDGE/VISTA with System
Enhancement Package
(K964626) |
| Standard Imaging Sequences | Same standard imaging
sequences with the addition of the
AcuScan package. | 2DFT: Field Echo, Spin Echo,
Multiple Echo, Inversion
Recovery and FAST.
3DFT: FAST | 2DFT: Field Echo, Spin Echo,
Multiple Echo, Inversion
Recovery and FAST.
3DFT: FAST |
| Acquisition and Reconstruction
Techniques | Same as K964626. | Main features include:
Presaturation, phase conjugate
symmetry, TrueRes, TrueSlice,
and Geometric Distortion
Correction. | Main features include:
Presaturation, phase conjugate
symmetry, TrueRes and TrueSlice. |
PICKER INTERNATIONAL, INC.
I.
5/8/97
I - 2
'معرب ا
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PICKER INTERNATIONAL, INC.
..
(APOLLO)
5/8/97
I - 3
نسببها
3
' · مسلا
PICKER INTERNATIONAL, INC.
)
5/8/97
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PICKER INTERNATIONAL, INC.
امارات سنڌ ا
5/21/97
I - 5
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PICKER INTERNATIONAL, INC.
I - 6
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| ITEM | ASSET APOLLO | Predicate Device
ASSET (K933835) | Predicate Device
EDGE/VISTA with System
Enhancement Package
(K964626) |
|------------------------------------------------|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Optional Receive Only Coils
and Accessories | Same as K933835. | Large Joint Coil
Small Joint Coil
Volume Neck Coil
Quad Spine Coil and Positioner
Bilateral TMJ Coil (Linear and
Phased Array versions)
Bilateral Breast Coil
General Purpose Flex Coil
C/T/L Phased Array
Pelvic Phased Array
Flexible Body Coil - Quadrature
Quadrature Wrist Coil
Quadrature Lower Extremity Coil
Coil Combiner | Large Joint Coil
Small Joint Coil
Volume Neck Coil
Quad Spine Coil and Positioner
Bilateral TMJ Coil (Linear and
Phased Array versions)
Bilateral Breast Coil
General Purpose Flex Coil
C/T/L Phased Array
Pelvic Phased Array
Flexible Body Coil (Quadrature
and Phased Array versions)
Quadrature Wrist Coil
Quadrature Lower Extremity Co
Coil Combiner
Head-Neck Vascular Phased A
Shoulder Phased Array |
| ITEM | ASSET APOLLO | Predicate Device
ASSET (K933835) | Predicate Device
EDGE/VISTA with System
Enhancement Package
(K964626) |
| Software Options | Angiography | Angiography | Angiography |
| | Cardiac Imaging | Cardiac Imaging | Cardiac Imaging |
| | Variable Fast Spin Echo
Sequences (2, 4, 8, 16, 32, 48 and
64 echo sequences) | Variable Fast Spin Echo
Sequences. | Variable Fast Spin Echo (2, 4, 8,
16, 32, 48 and 64 echo sequences) |
| | Gradient-Recalled and Spin-Echo
(GRaSE) Technique | Gradient-Recalled and Spin-Echo
(GRaSE) Technique | Gradient-Recalled and Spin-Echo
(GRaSE) Technique |
| | Echo Planar Imaging | Echo Planar Imaging | Echo Planar Imaging |
| Time Varying Magnetic Field | Same as K964626. | Not to exceed 20 T/s. | Normal Operating Mode:
dB/dt ≤ 40 T/s |
| | | | First Controlled Operating Mode:
40 T/s