(60 days)
The Panorama 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.
Philips' Panorama Enhancements includes changes to the operating limits for dB/dt and additional software improvements.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Philips Panorama Enhancements, structured according to your request.
Please note: This document describes a submission for a Magnetic Resonance Imaging (MRI) System, specifically "Panorama Enhancements". The information provided is primarily focused on demonstrating substantial equivalence to existing predicate devices, rather than a clinical study establishing new diagnostic performance metrics for an AI algorithm. Therefore, many of your requested points related to AI performance, ground truth, and expert evaluation are not applicable or extractable from this type of documentation.
Acceptance Criteria and Study for Philips Panorama Enhancements
This submission focuses on demonstrating substantial equivalence of the "Panorama Enhancements" to previously cleared MRI systems (Philips Panorama 0.6T/0.23T and Philips Intera family). The acceptance criteria for this type of submission are primarily related to meeting performance standards and maintaining safety and effectiveness comparable to the predicate devices. The "study" described is essentially a comparison table (Substantial Equivalence Chart) demonstrating how the new enhancements align with or are within the acceptable ranges of the predicate devices.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission for an MRI system enhancement, the "acceptance criteria" are implied to be the specifications and performance characteristics of the predicate devices, and the "reported device performance" is how the new "Panorama Enhancements" compare to these predicates.
| Parameter | Acceptance Criteria (Predicate Devices - K013858, K974844, K001796) | Reported Device Performance (Panorama Enhancements - 0.6T MR Imaging System) | Reported Device Performance (Panorama Enhancements - 0.23T MR Imaging System) |
|---|---|---|---|
| Gradient Coils | Water-cooled self-shielded gradient system (K013858, K974844) | Same (Water-cooled self-shielded gradient system) | Same (Water-cooled self-shielded gradient system) |
| Max. Gradient Strength (0.6T) | 20 mT/m (K013858) | 23 mT/m | N/A |
| Max. Gradient Strength (0.23T) | 16 mT/m (x,y direction), 18 mT/m (z direction) (K974844) | N/A | 21 mT/m |
| Max. Slew Rate (0.6T) | 40 T/m/s (K013858) | 75 T/m/s | N/A |
| Max. Slew Rate (0.23T) | 25 T/m/s (x,y direction), 40 T/m/s (z direction) (K974844) | N/A | 50 T/m/s |
| RF amplifiers | Max power 9 kW (K013858) for 0.6T; 5 kW solid state (K013858) for 0.23T | Same (Max power 9 kW) | Same (5 kW solid state) |
| RF transmitter coils | Upper and lower, planar coils, integrated in magnet, water cooling. Tuning adjusted to 0.6T/0.23T field strength (K013858) | Same | Same |
| Receive only RF coils | Head, Head and Neck, Neck, Extremity, Body and Spine, Multipurpose, TMJ, Breast, Shoulder (K013858, K974844, K002539, K981959, K013528, K983143) | Same and Synergy Head and Neck | Same and Synergy Body |
| Magnet Façade | Fiberglass enclosure (K013858, K974844) | New design, cover backdoor of ABS, otherwise material the same. | New design, cover backdoor of ABS, otherwise material the same. |
| Base Software | Windows 2000 based Graphical User Interface and scan / reconstruction software with multi-tasking capability (K013858) | Same | Same |
| MRGP software | Interventional MRI capabilities (K013858) | Same | Same |
| Imaging sequences | 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 (K013858) | Same | Same |
| Acquisition and reconstruction techniques | Presaturation, MAST, ODA, PCS, no phase wrap-around, no slice wrap around, dynamic imaging, cardiac gating, optimized bandwidth, turbo multislice, MAO, 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. SENSE capability. SyncraScan (K013858, K001796) | Same | Same |
| User Interface | Layout, see Figure 2a (K013858) | Layout change, see Figure 2b. | Layout change, see Figure 2b. |
| Normal Operating Mode (Time Varying) | According to IEC 60601-2-33 FDIS script 2001-11-02, default (K013858) for 0.6T; ≤ 40 T/s (K974844) for 0.23T | ≤ 35.4 T/s (IEC60601-2-33, second edition, directly determined) | ≤ 35.4 T/s (IEC60601-2-33, second edition, directly determined) |
| First Level Controlled Operating Mode (Time Varying) | According to IEC 60601-2-33 FDIS script 2001-11-02, default (K013858) for 0.6T; ≤ 60 T/s (K974844) for 0.23T | ≤ 44.3 T/s (IEC60601-2-33, second edition, directly determined) | ≤ 44.3 T/s (IEC60601-2-33, second edition, directly determined) |
| Normal Operating Mode (Radiofrequency Absorption) | Limited to a maximum level of 1.2 W/kg (K013858, K974844) | Same | Same |
| First Level Controlled Operating Mode (Radiofrequency Absorption) | Limited to a maximum value of 3.2 W/kg (K013858, K974844) | Same | Same |
| Acoustic Noise (Typical) | 87 dBA (average) 102 dBA (peak) (K013858) for 0.6T; A-weighted average value < 85 dBA (K974844) for 0.23T | Same | Same |
| Acoustic Noise (Worst Case) | 91 dBA (average), 104 dB (peak) (K013858) for 0.6T; A-weighted average value < 85 dBA, 98 dB peak (K974844) for 0.23T | Same | Same |
| Intended Use and Indications for Use | "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." (K013858) | Same, note the system name change. (The Panorama Enhancements do not change the existing indications for the Panorama 0.6T or 0.23T MR imaging systems.) | Same, note the system name change. (The Panorama Enhancements do not change the existing indications for the Panorama 0.6T or 0.23T MR imaging systems.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a "test set" in the context of an AI/algorithm performance study. The submission is for hardware and software enhancements to an MRI system, demonstrating substantial equivalence to predicate devices based on technical specifications and safety standards. There is no mention of a dataset of patient images being "tested" for diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/algorithm performance study requiring expert ground truth establishment for a dataset. The "ground truth" for the device's functionality is its adherence to established MRI performance parameters and safety standards. The interpretation of images for diagnosis is mentioned as being performed by a "trained physician," which is a general statement about the intended use of MRI and not specific to a study assessing device performance against expert readers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an MRMC study and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document describes enhancements to an MRI system, which is a diagnostic tool, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of submission, "ground truth" is measured against established engineering specifications, safety standards (like IEC 60601-2-33), and the documented performance characteristics of predicate devices. The device's "performance" is in its ability to generate images with specific physical parameters, not in interpreting those images for a diagnosis.
8. The sample size for the training set
Not applicable. No training set for an AI algorithm is mentioned or implied.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI algorithm is mentioned or implied.
{0}------------------------------------------------
Kò2 4042
SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)
1. General Information
| Classification: | Class IIMagnetic Resonance Imaging (MRI) System |
|---|---|
| Common/Usual Name: | Magnetic Resonance Imaging (MRI) System |
| Proprietary Name: | Panorama Enhancements |
| Establishment Registration: | Manufacturing Location:Philips Medical SystemsMR Technologies Finland OyP.O. Box 185Vantaa, FinlandFIN-00511Phone: 358925359300FDA Facility Registration: #9680194FDA Owner #1580240Contact:Attn: Duane C. PraschanPhilips Medical Systems (Cleveland)595 Miner RoadHighland Heights, OH 44143Phone: 440-483-5743 |
| Performance Standards: | No applicable performance standards havebeen issued under section 514 of the Food,Drug and Cosmetic Act |
2. Intended Uses
The Panorama Enhancements do not change the existing indications for the Panorama 0.6T or 0.23T MR imaging systems as defined below:
The Panorama 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 training physician, these images yield information that can be useful in the determination of a diagnosis.
3. Device Description
| Philips Medical Systems | Panorama Enhancements | 11/22/02 | Att I |
|---|---|---|---|
| MR Technologies Finland Oy | page 1 / 6 |
{1}------------------------------------------------
Philips' Panorama Enhancements includes changes to the operating limits for dB/dt and additional software improvements.
Safety and Effectiveness
The functionality included in the Panorama Enhancements are similar in technology characteristics and intended use to the Panorama 0.6T and 0.23T MR Imaging Systems and Philips' Intera family.
| Parameter | Panorama0.6T MRImagingSystem | Predicate Device- Philips Panorama0.6T SystemK013858- Philips Interafamily (0.5T, 1.0T,1.5T) K001796 | Panorama 0.23T MR ImagingSystem | Predicate Device- Philips Panorama 0.6T SystemK013858- Philips Panorama 0.23 T SystemK974844- Philips Intera family (0.5T, 1.0T,1.5T) K001796 |
|---|---|---|---|---|
| GradientSubsystem | ||||
| Gradient Coils: | Same. | Water-cooled self-shielded gradientsystem. K013858 | Same. | Water-cooled self-shielded gradientsystem. K974844 |
| Max. GradientStrength: | 23 mT/m. | 20 mT/m K013858 | 21 mT/m | 16 mT/m (x,y direction), 18 mT/m (zdirection) K974844 |
| Max. SlewRate: | 75 T/m/s. | 40 T/m/s K013858 | 50 T/m/s | 25 T/m/s (x,y direction), 40 T/m/s (zdirection) K974844 |
| RF Subsystem | ||||
| RF amplifiers: | Same. | Max power 9 kWK013858 | Same. | 5 kW solid state K013858 |
| RF transmittercoils: | Same. | Upper and lower,planar coils,integrated in themagnet, watercooling. Tuningadjusted to 0.6T fieldstrength. K013858 | Same. | Upper and lower, planar coils, integratedin the magnet. Tuning adjusted to 0.23Tfield strength. K013858 |
| Receive onlyRF coils: | Same andSynergyHead andNeck | Head, Head andNeck, Neck,Extremity, Body andSpine, Multipurpose(different sizes), TMJ,Breast, Shoulder.K013858 | Same andSynergy Body. | Head, Brain, Head and Neck, Neck,Extremity, Body and Spine (differentsizes), Flexible spine, Flexible Multi-Purpose (different sizes), SmallExtremity (K974844)Breast (K002539, MRI Devices Corp.)Large Neck (K981959 PickerInternational, Inc.)TMJ (013528, USA Instruments, Inc.)Shoulder (K983143,USA Instruments,Inc.) |
| MagnetEnclosure | ||||
| Parameter | Panorama0.6T MRImagingSystem | Predicate Device- Philips Panorama0.6T SystemK013858- Philips Interafamily (0.5T, 1.0T,1.5T) K001796 | Panorama 0.23T MR ImagingSystem | Predicate Device- Philips Panorama 0.6T SystemK013858- Philips Panorama 0.23 T SystemK974844- Philips Intera family (0.5T, 1.0T,1.5T) K001796 |
| MagnetFaçade: | New design,coverbackdoor ofABS,otherwisematerial thesame. | Fiberglass enclosure.K013858 | New design,cover backdoorof ABS,otherwisematerial thesame. | Fiberglass enclosure. K974844 |
| OperatingSoftware | ||||
| Base Software: | Same. | Windows 2000 basedGraphical UserInterface and scan /reconstructionsoftware with multi-tasking capability.K013858 | Same. | Windows 2000 based Graphical UserInterface and scan / reconstructionsoftware with multi-tasking capability.K013858 |
| MRGPsoftware: | Same. | Interventional MRIcapabilities. K013858 | Same. | Interventional MRI capabilities.K013858 |
| Imagingsequences | ||||
| Main featuresinclude: | Same. | Field Echo, SpinEcho, Dual Echo,Dual Spin Echo,Inversion Recovery,Dual InversionRecovery, Fast SpinEcho, EXPRESS,CBASS, MRCP,MRA, STIR,FLAIR, TSHIRT, RF-FAST, CE-FAST,DWISE. K013858 | Same. | Field Echo, Spin Echo, Dual Echo, DualSpin Echo, Inversion Recovery, DualInversion Recovery, Fast Spin Echo,EXPRESS, CBASS, MRCP, MRA,STIR, FLAIR, TSHIRT, RF-FAST, CE-FAST, DWISE. K013858 |
| Acquisition andreconstructiontechniques | ||||
| Parameter | Panorama0.6T MRImagingSystem | Predicate Device- Philips Panorama0.6T SystemK013858- Philips Interafamily (0.5T, 1.0T,1.5T) K001796 | Panorama 0.23T MR ImagingSystem | Predicate Device- Philips Panorama 0.6T SystemK013858- Philips Panorama 0.23 T SystemK974844- Philips Intera family (0.5T, 1.0T,1.5T) K001796 |
| Main featuresinclude: | Same. | Presaturation, MAST,ODA, PCS, no phasewrap-around, no slicewrap around, dynamicimaging, cardiacgating, optimizedbandwidth, turbomultislice.MAO, MAST,presaturation,chemical fatsaturation, phaseconjugate symmetry,read conjugatesymmetry, true res,true slice, ellipticencoding, RAM,CODA, MTC,dynamic examinationcurve, contrastdynamic imaging,reconstruction filters,respiratory gating,multiplanarreconstruction,maximum intensityprojection, phasecorrection, fat/watersuppression, ADCmap. K013858SENSE capability.K001796SyncraScan | Same. | Presaturation, MAST, ODA, PCS, nophase wrap-around, no slice wraparound, dynamic imaging, cardiacgating, optimized bandwidth, turbomultislice.MAO, MAST, presaturation, chemicalfat saturation, phase conjugatesymmetry, read conjugate symmetry,true res, true slice, elliptic encoding,RAM, CODA, MTC, dynamicexamination curve, contrast dynamicimaging, reconstruction filters,respiratory gating, multiplanarreconstruction, maximum intensityprojection, phase correction, fat/watersuppression, ADC map. K013858SENSE capability. K001796SyncraScan |
| User Interface | Layoutchange, seeFigure 2b. | Layout, see Figure 2a. | Layout change,see Figure 2b. | Layout, see Figure 2a. |
| Time Varying | ||||
| Parameter | Panorama0.6T MRImagingSystem | Predicate Device- Philips Panorama0.6T SystemK013858- Philips Interafamily (0.5T, 1.0T,1.5T) K001796 | Panorama 0.23T MR ImagingSystem | Predicate Device- Philips Panorama 0.6T SystemK013858- Philips Panorama 0.23 T SystemK974844- Philips Intera family (0.5T, 1.0T,1.5T) K001796 |
| NormalOperatingMode: | ≤ 35.4 T/s(IEC60601-2-33,secondedition,directlydetermined) | According to IEC60601-2-33 FDISscript 2001-11-02,default. K013858 | ≤ 35.4 T/s(IEC60601-2-33, secondedition, directlydetermined) | ≤ 40 T/s K974844 |
| First LevelControlledOperatingMode: | ≤ 44.3 T/s(IEC60601-2-33,secondedition,directlydetermined) | According to IEC60601-2-33 FDISscript 2001-11-02,default. K013858 | ≤ 44.3 T/s(IEC60601-2-33, secondedition, directlydetermined) | ≤ 60 T/s K974844 |
| RadiofrequencyAbsorption | ||||
| NormalOperatingMode: | Same. | Limited to amaximum level of 1.2W/kg. K013858 | Same. | Limited to a maximum level of 1.2W/kg. K974844 |
| First LevelControlledOperatingMode: | Same. | Limited to amaximum value of3.2 W/kg.K013858 | Same. | Limited to a maximum value of 3.2W/kg.K974844 |
| Acoustic Noise | ||||
| Typical: | Same. | 87 dBA (average)102 dBA (peak)K013858 | Same. | A-weighted average value < 85 dBAK974844 |
| Worst Case: | Same. | 91 dBA (average),104 dB (peak)K013858 | Same. | A-weighted average value < 85 dBA, 98dB peak K974844 |
Substantial Equivalence Chart
Philips Medical Systems MR Technologies Finland Oy Panorama Enhancements 11/22/02 Att I page 2 / 6
{2}------------------------------------------------
{3}------------------------------------------------
{4}------------------------------------------------
{5}------------------------------------------------
| Parameter | Panorama0.6T MRImagingSystem | Predicate Device- Philips Panorama0.6T SystemK013858- Philips Interafamily (0.5T, 1.0T,1.5T) K001796 | Panorama 0.23T MR ImagingSystem | Predicate Device- Philips Panorama 0.6T SystemK013858- Philips Panorama 0.23 T SystemK974844- Philips Intera family (0.5T, 1.0T,1.5T) K001796 |
|---|---|---|---|---|
| Intended UseandIndications forUse | Same, notethe systemnamechange. | The Proview Systemis indicated for use asa NMR device thatproduces images that:(1) correspond to thedistribution of protonsexhibiting NMR, (2)depend upon theNMR parameters(proton density, flowvelocity, spin-latticerelaxation time (T1),and spin-spinrelaxation time (T2))and (3) display thesoft tissue structure ofthe head and wholebody. Wheninterpreted by atrained physician,these images yieldinformation that canbe useful in thedetermination of adiagnosis. K013858 | Same, note thesystem namechange. | The Proview System is indicated for useas a NMR device that produces imagesthat: (1) correspond to the distribution ofprotons exhibiting NMR, (2) dependupon the NMR parameters (protondensity, flow velocity, spin-latticerelaxation time (T1), and spin-spinrelaxation time (T2)) and (3) display thesoft tissue structure of the head andwhole body. When interpreted by atrained physician, these images yieldinformation that can be useful in thedetermination of a diagnosis. K013858 |
:
.
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a triple-lined design resembling an abstract bird or wing-like shape, oriented diagonally within the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 0 4 2003
Mr. Duane C. Preschan Manager, MR Regulatory Affairs Philips, Medical Systems, Inc. 595 Miner Road HIGHLAND HEIGHTS OH 44143 Re: K024042
Trade/Device Name: Panorama Enhancements Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: November 22, 2002 Received: December 6, 2002
Dear Mr. Preschan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
{7}------------------------------------------------
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{8}------------------------------------------------
510(k) Number (if known):
Device Name: Panorama Enhancements
Indications for Use:
Intended Use
The Panorama Enhancements do not change the existing indications as defined below.
The Panorama 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K024042 |
|---|---|
| --------------- | --------- |
Prescription Use V (Per 21 CFR 801.109) OR
Over-The-Counter Use (Optional Format 1-2-96)
§ 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.