(62 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware, software changes, and imaging sequences, not AI/ML capabilities.
No
The device is indicated for imaging and diagnosis, not for treating diseases or conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device produces images that, "When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis." This indicates its role in the diagnostic process.
No
The device description explicitly states that the submission describes "hardware and software changes" for a Magnetic Resonance Imaging system, indicating it is a hardware device with associated software, 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 produces images of the body for diagnostic purposes when interpreted by a trained physician. This is the core function of an imaging device, not an IVD.
- Device Description: The description confirms it's a Magnetic Resonance Imaging (MRI) system, which is an imaging modality, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVDs are devices used to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is an imaging system that visualizes the internal structure of the body.
N/A
Intended Use / Indications for Use
The Infinion 0.6T MR Imaging System does not change the existing indications as defined below.
The Infinion 0.6T MR Imaging 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
This submission describes the hardware and software changes for the Philips' 0.6T Open Magnetic Resonance Imaging system, the Infinion 0.6T.The package also includes additional imagin sequences and acquisition/construction techniques. However, the basic features are unchanged.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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
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)
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
Kol 3858
SUMMARY OF SAFETY AND EFFECTIVENESS JAN 2 2 2002
(As required by 21 CFR 807.92)
JAN 2 2 2002
General Information 1.
| Classification: | Class II
Magnetic Resonance Imaging (MRI) System |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetic Resonance Imaging (MRI) System |
| Proprietary Name: | Infinion 0.6T MR Imaging System |
| Establishment Registration: | Manufacturer:
Philips Medical Systems MR Technologies Finland, Inc.
P.O. Box 185
FIN-00511 Vantaa, Finland
Phone: +358-9-2535-9300
Fax: +358-9-2535-9600
FDA Facility Registraton #9680194
United States Representative:
Philips Medical Systems (Cleveland), Inc.
595 Miner Road
Highland Heights, Ohio 44143
Contact: Duane C. Praschan
Phone: (440) 483-3000
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 Infinion 0.6T MR Imaging System does not change the existing indications as defined below.
The Infinion 0.6T MR Imaging 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
K013858
page 1 of 3
3. Device Description
This submission describes the hardware and software changes for the Philips' 0.6T Open Magnetic Resonance Imaging system, the Infinion 0.6T.The package also includes additional imagin sequences and acquisition/construction techniques. However, the basic features are unchanged.
4. Safety and Effectiveness
The functionality included in Philips' Infinion 0.6T MR Imaging System is similar in technological characteristics and intended use to the Proview 0.23T MR. The following table has been created to demonstrate their substantial equivalence.
| Parameter | Infinion 0.6T MR Imaging System | Predicate Device - Philips
Proview 0.23T System (K974844) |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Computer Subsystem | | |
| Display/database system: | Same. | Single display for system operation and
image reviewing, workstation tower,
moveable keyboard and mouse, CD-ROM.
Allows for simultaneous scanning and image
reconstruction/manipulation. Image storage
via magneo-optical disk. |
| Network communications: | DICOM Query/Retrieve, DICOM
Modality WL Management. | Display/Database computer and scan
reconstruction hardware connected together
by fast Ethernet communications system.
DICOM compliant for transfer of images to
other systems. |
| Gradient Subsystem | | |
| Gradient Coils: | Same. | Water-cooled self-shielded gradient system. |
| Max. Gradient Strength: | 20 mT/m | 16 mT/m (XY), 18 mT/m (Z) |
| Max. Slew Rate: | 40 T/m/s | 25 mT/m/msec (XY), 40 mT/m/msec (Z). |
| RF Subsystem | | |
| RF Amplifiers: | Max power 9 kW. | 5 kW solid state. |
| RF transmitter coils: | Same but with tuning adjusted to proton
resonance at 0.6T field strength instead
of 0.23 T, and with water cooling. | Upper and lower, planar coils, integrated in
the magnet. |
| Parameter | Infinion 0.6T MR Imaging System | Predicate Device - Philips
Proview 0.23T System (K974844) |
| Receive only RF coils: | Head (phased array two-channel)
Head and Neck (phased array four-
channel).
Neck (phased array two-channel)
Extremity (phased array two-channel)
Body & Spine, different sizes (phased
array two-channel)
Multipurpose, different sizes (linear
single-channel) | Head (phased array two-channel).
Brain (phased array two-channel).
Head and Neck (phased array four-channel,
formerly Vascular Head and Neck).
Neck (phased array two-channel).
Extremity (phased array two-channel).
Body and Spine, different sizes (phased array
two-channel)
Flexible Spine (phased array two-channel).
Flexible Multipurpose, different sizes (linear
single-channel).
Small Extremity (phased array two-channel,
earlier name Small Joints).
Large Neck (phased array two-channel). |
| Receive only coil connection: | All receive only coils plug into the RF
connectors in both ends of the patient
couch. | All receive only coils plug into the RF
connector on the front of the magnet façade. |
| Magnet Subsystem | | |
| Magnet Type: | 0.6 T superconducting | 0.23 T iron-core electromagnetic. |
| Patient Handling | | |
| Patient couch: | Motorized movement in three
orthogonal dimensions. Optional
trolley which can be used for
transporting the couch upper part
together with the coil and patient.
Couch weight capacity is 220 kg.
Remote control of the couch in
horizontal direction. | Computer and couch controlled patient
transport system with 200 kg weight capacity.
Optional couch with vertical movement. |
| Patient positioning: | Same laser positioning marker.
Additional automated stepping
capabilities. | Laser positioning marker for accurate
placement of patient at isocenter. |
| Patient communication: | Same. | Two-way intercom system and hand-held
audio alarm. |
| Magnet Enclosure | | |
| Magnet Façade: | Same. | Fiberglass enclosure. |
| Controls: | LCD display above bore capable of
displaying system status. Two keypads
on either side of bore for system
controls. | LED display capable of display system
status. Control panel in upper front pole. |
| Power Distribution Subsystem | | |
| Subsystem components: | Same. | Isolation transformer, transient suppression
circuitry, and power distribution center all
contained in a single cabinet. |
| Operating Software | | |
| Base Software: | Same. | Windows 2000 based Graphical User
Interface and scan / reconstruction software
with multi-tasking capability. |
| | Infinion 0.6T MR Imaging System | Predicate Device – Philips
Proview 0.23T System (K974844) |
| Parameter | | |
| Imaging sequences
Main features include: | Field Echo, Spin Echo, Dual Echo,
Dual Spin Echo, Inversion Recovery,
Dual Inversion Recovery, Fast Spin
Echo, EXPRESS, CBASS, MRCP,
MRA, STIR, FLAIR, TSHIRT, RF-
FAST, CE-FAST, DWISE. | Field Echo, Spin Echo, Dual Echo, Inversion
Recovery, Fast Spin Echo, CBASS, MRCP,
MRA, STIR. |
| Acquisition and reconstruction
techniques
Main features include: | Same and additionally MAO, MAST,
presaturation, chemical fat saturation,
phase conjugate symmetry, read
conjugate symmetry, true res, true slice,
elliptic encoding, RAM, CODA, MTC,
dynamic examination curve, contrast
dynamic imaging, reconstruction filters,
respiratory gating, multiplanar
reconstruction, maximum intensity
projection, phase correction, fat/water
suppression, ADC map. | Presaturation, MAST, ODA, PCS, no phase
wrap-around, no slice wrap around, dynamic
imaging, cardiac gating, optimized
bandwidth, turbo multislice. |
| Time Varying Magnetic Field
Normal Operating Mode: | According to 60601-2-33 FDISscript
2001-11-02. | dB/dt ≤ 20 T/s |
| First Level Controlled
Operating Mode: | According to 60601-2-33 FDISscript
2001-11-02. | Not applicable. |
| Radiofrequency Absorption
Normal Operating Mode: | Same. | Limited to a maximum level of 1.2 W/kg. |
| First Level Controlled
Operating Mode: | Same. | Limited to a maximum value of 3.2 W/kg. |
| Acoustic Noise
Typical: | 87 dBA (average)
102 dB (peak) | ✓ | | | (Optional Format 1-2-96) |
Jansylf Brydon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K013858 |
|---|---|
| --------------- | ---------------- |