(32 days)
The IMRIS Oncology package uses the IMRISneuro family of Intra-operative MRI systems/Siemens MAGNETOM MR systems indicated for use as a diagnostic imaging device that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that display the internal structure and / or function of the entire body, including, but not limited to head, neck, and pelvis regions. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The IMRIS Oncology Package provides an additional patient tabletop for IMRIS MR systems /Siemens MAGNETOM that allows patients to be imaged on a flat surface. The flat patient surface enables IMRIS MR system/Siemens MAGNETOM to acquire images in patient positions similar to other modalities that also utilize a flat patient surface such as X-ray, CT, PET and radiation therapy.
The IMRIS MR systems/Siemens MAGNETOM MR Systems with IMRIS Oncology Package may also be used with MR safe/MR conditional patient positioning and immobilization accessories to assist in obtaining consistent patient positions throughout multiple imaging sessions.
The IMRIS Oncology Package provides an additional patient tabletop (MR SIMS table top) that can be used with IMRIS Neuro 1.5T / Siemens MAGNETOM 1.5T MRI scanners for radiation therapy planning. The MR SIMS table top allows patients to be imaged on a flat surface that matches the imaging patient position. The oncology package includes Head and Neck coil (HNC150) and Pelvic coil (PCC 150). Used in the IMRISneuro 1.5Tsystem/Siemens MAGNETOM 1.5 Tesla, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal, and oblique images of the internal structures of the head, neck and pelvic regions. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The IMRIS HNC150 and PCC150 coils can also be used as standard diagnostic head coils and pelvic coil respectively for diagnostic examinations. The Oncology package may be used with MR-conditional/ MR safe patient immobilization accessories to assist in consistent positions throughout multiple imaging sessions.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device: IMRIS Oncology Package (K121997)
This submission is for an IMRIS Oncology Package, which includes an additional patient tabletop (MR SIMS table top), Head and Neck coil (HNC150), and Pelvic coil (PCC150) for use with IMRIS Neuro 1.5T / Siemens MAGNETOM 1.5T MRI scanners. Its primary intended use is for radiation therapy planning, allowing patients to be imaged on a flat surface similar to other modalities like X-ray, CT, and PET.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes design verification and validation tests (bench testing) rather than specific quantitative "acceptance criteria" against which a statistical performance metric is measured (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on compliance with standards and successful completion of various engineering and clinical image comparison tests.
| Acceptance Criteria Category | Specific Test/Criteria | Reported Device Performance |
|---|---|---|
| Electrical, Mechanical, and Flammability Hazards | IEC 60601-1 compliance | "The IMRIS Oncology Package passed the following tests and meets product specifications." "The oncology package is tested for electrical, mechanical, and flammability hazards. The IMRIS Oncology package complies with voluntary standards (IEC 60601-2-33, and UL 94)." "The tests outlined above have been executed with acceptable results." |
| IEC 60601-2-33 compliance | "The IMRIS Oncology Package passed the following tests and meets product specifications." "The oncology package is tested for electrical, mechanical, and flammability hazards. The IMRIS Oncology package complies with voluntary standards (IEC 60601-2-33, and UL 94)." "The tests outlined above have been executed with acceptable results." | |
| MRI Safety & Performance (Imaging) | MRI compatibility test (MR image artifacts test) | "The IMRIS Oncology Package passed the following tests and meets product specifications." "The HNC 150 and PCC 150 coils are tested for MR image artifacts and surface heating test." "The tests outlined above have been executed with acceptable results." |
| MRI compatibility test (MR heating test / Surface heating (normal and single fault conditions)) | "The IMRIS Oncology Package passed the following tests and meets product specifications." "The HNC 150 and PCC 150 coils are tested for MR image artifacts and surface heating test." "The tests outlined above have been executed with acceptable results." | |
| Single fault condition unplugged (passive detuning test) | "The IMRIS Oncology Package passed the following tests and meets product specifications." "The tests outlined above have been executed with acceptable results." | |
| Head and Neck coil (HNC150) Image Non-Uniformity and SNR Measurement | "SNR was measured and is reported in accordance with NEMA MS 9-2008 Characterization of Special Purpose Coils for Diagnostic Resonance Images. The NEMA MS 9-2008 references the ALTERNATE MEASUREMENT PROCEDURE as described in NEMA MS 6-2008." "The HNC 150 and PCC 150 coils SNR and Image non-uniformity are tested according to NEMA standards." "The tests outlined above have been executed with acceptable results." | |
| Pelvic coil (PCC150) Image Non-Uniformity and SNR Measurement | "SNR was measured and is reported in accordance with NEMA MS 9-2008 Characterization of Special Purpose Coils for Diagnostic Resonance Images. The NEMA MS 9-2008 references the ALTERNATE MEASUREMENT PROCEDURE as described in NEMA MS 6-2008." "The HNC 150 and PCC 150 coils SNR and Image non-uniformity are tested according to NEMA standards." "The tests outlined above have been executed with acceptable results." | |
| Clinical Effectiveness / Imaging Quality | Clinical image comparison | "The IMRIS Oncology Package passed the following tests and meets product specifications." "The Oncology Package provided clinical images which demonstrate the clinical effectiveness of the Oncology package." "The tests outlined above have been executed with acceptable results." "Performance data demonstrate safety and effectiveness of the IMRIS Oncology Package." |
| Functional/Workflow | Workflow | "The IMRIS Oncology Package passed the following tests and meets product specifications." "The tests outlined above have been executed with acceptable results." |
| Loading test | "The IMRIS Oncology Package passed the following tests and meets product specifications." "The tests outlined above have been executed with acceptable results." | |
| Overall Safety and Effectiveness / Substantial Equivalence | Compliance with predicate device's intended use and indications for use. | "The IMRIS Oncology Package has the same intended use and indications for use as the predicate devices. Performance data demonstrate safety and effectiveness of the IMRIS Oncology Package with the new characteristics." "The IMRIS Oncology Package verification results and performance/safety standard results show that the device is safe and effective and substantially equivalent to the currently available predicate device, GE MR Radiation Oncology options." |
2. Sample size used for the test set and the data provenance
- The document does not specify a numerical sample size for the "clinical image comparison" or other tests.
- Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are described as "Design Verification and Validation Test (Bench Testing)" which suggests these were conducted in a controlled, engineering test environment rather than a large-scale clinical study with real patient data from specific geographical locations. The "clinical image comparison" would likely have involved imaging a small number of volunteers or phantoms, or a small selection of patient cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the summary. For "clinical image comparison," it is implied that a "trained physician" would interpret the images, but the number or specific qualifications for establishing ground truth are not detailed.
4. Adjudication method for the test set
- An adjudication method is not mentioned in the summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study is not described or implied in the provided text. The submission focuses on device safety, performance, and substantial equivalence to a predicate device through bench testing and image quality assessments, not comparative effectiveness with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is an MRI accessory package (tabletop and coils), not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable to this submission. The device produces images that are then interpreted by a trained physician.
7. The type of ground truth used
- For the "clinical image comparison," the ground truth is implicitly expert interpretation by "a trained physician" (as stated in the Indications for Use). For the technical tests (SNR, non-uniformity, artifacts), the "ground truth" would be the NEMA standards themselves and engineering specifications. Pathology or outcomes data are not indicated as ground truth types for this submission.
8. The sample size for the training set
- This device is an MRI accessory package and does not describe an AI algorithm or a "training set" in the context of machine learning. Therefore, this question is not applicable.
9. How the ground truth for the training set was established
- As the device is an MRI accessory package and not an AI algorithm, there is no training set and thus no ground truth established for a training set.
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IMRIS
AUG 1 0 2012
510(k) Summary for Oncology Package
510(k) SUMMARY FOR IMRIS ONCOLOGY PACKAGE
(As required by 21 CFR 807.92)
1. GENERAL INFORMATION Establishment: IMRIS Inc. Address: 100-1370 Sony Place Winnipeg, Manitoba Canada, R3T 1N5 3003807210 Registration Number: Mr. Sanjay Shah Contact Person: QA and Regulatory Engineer Email: sshah@imris.com Phone: 1-204-480-7070 Fax: 1-204-480-7071 Date of Summary July 23, 2012 Preparation: Device Name / Trade name IMRIS Oncology Package Classification Name: Magnetic resonance diagnostic device. Classification Panel: Radiology Classification (CFR section): 21 CFR 892.1000 Class: Class II Product Code: LNH
2. PREDICATE DEVICES
The IMRIS Oncology Package is substantially equivalent to the following predicate medical devices.
| NAME OF THE DEVICE | 510(K) NUMBER | DATE OFCLEARANCE | MANUFACTURER |
|---|---|---|---|
| MR Radiation Oncology Options | K102155 | August 31, 2010 | GE Medical System,LLC |
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IMBIS
510(k) Summary for Oncology Package
3. DEVICE DESCRIPTION
The IMRIS Oncology Package provides an additional patient tabletop (MR SIMS table top) that can be used with IMRIS Neuro 1.5T / Siemens MAGNETOM 1.5T MRI scanners for radiation therapy planning. The MR SIMS table top allows patients to be imaged on a flat surface that matches the imaging patient position. The oncology package includes Head and Neck coil (HNC150) and Pelvic coil (PCC 150). Used in the IMRISneuro 1.5Tsystem/Siemens MAGNETOM 1.5 Tesla, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal, and oblique images of the internal structures of the head, neck and pelvic regions. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The IMRIS HNC150 and PCC150 coils can also be used as standard diagnostic head coils and pelvic coil respectively for diagnostic examinations. The Oncology package may be used with MR-conditional/ MR safe patient immobilization accessories to assist in consistent positions throughout multiple imaging sessions.
4. INDICATION FOR USE
The IMRIS Oncology package uses the IMRISneuro family of Intra-operative MRI systems /Siemens MAGNETOM MR systems indicated for use as a diagnostic imaging device that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that display the internal structure and / or function of the entire body, including, but not limited to head, neck, and pelvis regions. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
The IMRIS Oncology Package provides an additional patient tabletop for IMRIS MR systems /Siemens MAGNETOM that allows patients to be imaged on a flat surface. The flat patient surface enables IMRIS MR system/Siemens MAGNETOM to acquire images in patient positions similar to other modalities that also utilize a flat patient surface such as X-ray. CT, PET and radiation therapy.
The IMRIS MR systems/Siemens MAGNETOM MR systems with IMRIS Oncology Package may also be used with MR safe/MR conditional patient positioning and immobilization accessories to assist in obtaining consistent patient positions throughout multiple imaging sessions.
| Characteristic | GE MR Radiation Oncology Options | IMRIS Oncology Package |
|---|---|---|
| FDA 510(k) # | K102155 | Current Submission |
| Manufacturedby | GE Medical Systems, LLC | IMRIS Inc. |
| Intended use/Indications foruse | The MR Radiation Oncology Optionsare a patient positioning packageintended for use with the GE wide boreMR Scanners. The MR RadiationOncology Options when used with aGE wide bore MR scanner is a wholebody magnetic resonance scannerdesigned to support high resolution, | The IMRIS Oncology packageuses the IMRISneuro family ofIntra-operative MRIsystems/Siemens MAGNETOMMR systems indicated for use asa diagnostic imaging device thatproduce transverse, sagittal,coronal and oblique cross |
| 510(k) Summary for Oncology Package | ||
| high signal-to-noise ratio and shortscan times. The GE wide bore MRscanners with MR Radiation OncologyOptions are indicated for use as adiagnostic imaging device to provideaxial, sagittal, coronal, and obliqueimages, spectroscopic images, and/orspectra, dynamic images of the internalstructures and organs of the entirebody, including but not limited to head,neck, TMJ, spine, breast, heart,abdomen, pelvis joints, prostate, bloodvessels, and musculoskeletal regionsof the body. The images produced bythe GE wide bore scanners with MRRadiation Oncology Options reflect thespatial distribution of protons (hydrogennuclei) exhibiting magnetic resonance.These images and/or spectra wheninterpreted by a trained physician yieldinformation that may assist indiagnosis.The MR Radiation Oncology Optionsinclude a removable patient table insertfor GE wide bore MR scanners thatallow patients to be imaged on a flatsurface. The flat patient surface allowsimage acquisition in patient positionssimilar to other modalities that also usea flat patient surface such as X-Ray,CT, PET, and radiation therapy.The GE wide bore MR scanners withthe MR Radiation Oncology Optionsmay also be used with MR- compatiblepatient positioning and immobilizationaccessories to assist in obtainingconsistent patient positions throughoutmultiple imaging sessions. | sectional images, spectroscopicimages and / or spectra, andthat display the internalstructure and / or function of theentire body, including, but notlimited to head, neck, and pelvisregions. Depending on theregion of interest, contrastagents may be used. Theseimages and / or spectra wheninterpreted by a trainedphysician yield information thatmay assist in diagnosis.The IMRIS Oncology Packageprovides an additional patienttabletop for IMRIS MRsystems/Siemens MAGNETOMthat allows patients to beimaged on a flat surface. Theflat patient surface enablesIMRIS MR system/SiemensMAGNETOM to acquire imagesin patient positions similar toother modalities that also utilizea flat patient surface such as X-ray, CT, PET and radiationtherapy.The IMRIS MRsystems/Siemens MAGNETOMMR systems with IMRISOncology Package may also beused with MR safe/MRconditional patient positioningand immobilization accessoriesto assist in obtaining consistentpatient positions throughoutmultiple imaging sessions. | |
| Where used | Hospital Diagnostic room | Hospital Diagnostic room |
| Anatomicalsites | Entire body, including but not limited tohead, neck, TMJ, spine, breast, heart,abdomen, pelvis joints, prostate, bloodvessels, and musculoskeletal regionsof the body | Entire body, including, but notlimited to head, neck, and pelvisregions |
5. COMPARISION TO PREDICATE DEVICES
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:
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K12/997
IMRIS
510(k) Summary for Oncology Package
- SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE: (807.92 (A) (6))
.
| Characteristic | GE MR Radiation OncologyOptions | IMRIS Oncology Package | Comparison |
|---|---|---|---|
| FDA 510(k) # | K102155 | Current Submission | |
| MR-SIM table Top and S Frame mask adaptor | |||
| MR radiation oncologyposition insert | MR-SIM table top and S-frame adaptor | ||
| MRI systemCompatibility | GE 1.5T MRI scanners | Siemens MAGNETOM 1.5TMRI systems IMRIS 1.5TMRI systems | Same fieldStrength1.5Tesla |
| Surface | Flat Surface | Flat Surface | Same |
| Mobile patient table top withembedded high-density,posterior RF coil array | Table top with cavity allowsmounting of posterior coils | Similardesign | |
| Material | Fiber glass with foam core | Acetal | Different |
| MRI safety | MR compatible | MR safe | Same |
| S-Frame and maskconnecting withtable top | Yes | Yes | Same |
| IEC 60601-1compliance | Yes | Yes | Same |
| Head and Neck Coil (HNC 150) | |||
| GE head and neck coil (6-channel flex coil) | IMRIS Head and neckcoil (HNC150) | Comparison | |
| MRI systemCompatibility | GE 1.5T MRI Scanners | Siemens 1.5T MRIscannersIMRIS 1.5T MRI system | Same fieldstrength -1.5T MRIScanners |
| Coil Type | Receive-only six channelphased array coil | Receive-only eighteenchannel phased array coil | Similar |
| RF Cable Interface | Interface Cable withInsulated Cable Traps | Interface Cable withInsulated Cable Traps | Same |
| Tune and Match | No tune, no match | No tune, no match | Same |
| Safety features | Active and PassiveDecoupling | Active and PassiveDecoupling | Same |
| RF Fuse | New | ||
| Coil EnclosureMaterial and design | Vinyl coating closed cellfoam | Vinyl coating closed cellfoam | Same |
.
.
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K121997
IMRIS
510(k) Summary for Oncology Package
| Characteristic | GE MR Radiation Oncology Options | IMRIS Oncology Package | Comparison |
|---|---|---|---|
| FDA 510(k) # | K102155 | Current Submission | |
| Flexible | Flexible | Same | |
| IEC 60601-1 Compliance | Yes | Yes | Same IECstandards |
| Pelvic Coil (PCC 150) | |||
| GEM anterior array coilGEM posterior array coil | IMRIS Pelvic coil(PCC150) | Comparison | |
| MRI system Compatibility | GE 1.5T MRI Scanners | Siemens 1.5T MRIScannersIMRIS 1.5T MRI system | Same fieldstrength -1.5T MRIScanners |
| Coil Type | Receive-only up to 36channel phased array coil | Receive-only elevenchannel phased array coil | Similar |
| System connection | The coil plugs into the MRISystem | The coil plugs into the MRISystem | Same |
| RF Cable Interface | Interface Cable withInsulated Cable Traps | Interface Cable withInsulated Cable Traps | Same |
| Tune and Match | No tune, no match | No tune, no match | Same |
| Safety features | Active and PassiveDecoupling | Active and PassiveDecoupling | Same |
| RF Fuse | New | ||
| Coil EnclosureMaterial and design | Plastic, Vinyl coated closedcell foamFlexible | Plastic, Vinyl coatedclosed cell foamFlexible | Same |
| IEC 60601-1Compliance | Yes | Yes | Same |
.
:
:
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Image /page/5/Picture/1 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '121997'. The numbers are written in a simple, slightly slanted style, and the overall impression is that of a quickly jotted down code or identifier.
IMRIS
510(k) Summary for Oncology Package
7. SUMMARY OF NON-CLINICAL DATA
Design Verification and Validation Test (Bench Testing)
The IMRIS Oncology Package passed the following tests and meets product specifications. IMRIS has performed a number of V&V tests. The main tests include
- IEC 60601-1 compliance .
- . IEC 60601-2-33 compliance
- Clinical image comparison .
- MRI compatibility test (MR image artifacts test, MR heating test), .
- Surface heating (normal and single fault conditions) .
- Single fault condition unplugged (passive detuning test) .
- Workflow .
- Loading test .
- The Head and Neck coil (HNC150) and Pelvic coil (PCC 150) Image Non-Uniformity and . SNR was measured and is reported in accordance with NEMA MS 9-2008 Characterization of Special Purpose Coils for Diagnostic Resonance Images. The NEMA MS 9-2008 references the ALTERNATE MEASUREMENT PROCEDURE as described in NEMA MS 6-2008.
The oncology package is tested for electrical, mechanical, and flammability hazards. The IMRIS Oncology package complies with voluntary standards (IEC 60601-2-33, and UL 94). The Oncology Package provided clinical images which demonstrate the clinical effectiveness of the Oncology package. The HNC 150 and PCC 150 coils are tested for MR image artifacts and surface heating test. The HNC 150 and PCC 150 coils SNR and Image non-uniformity are tested according to NEMA standards. The tests outlined above have been executed with acceptable results. Performance data demonstrate safety and effectiveness of the IMRIS Oncology Package.
8. CONCLUSION
The IMRIS Oncology Package has the same intended use and indications for use as the predicate devices. Performance data demonstrate safety and effectiveness of the IMRIS Oncology Package with the new characteristics.
The IMRIS Oncology Package verification results and performance/safety standard results show that the device is safe and effective and substantially equivalent to the currently available predicate device, GE MR Radiation Oncology options.
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
—AUG—1-0—2012—
Mr. Sanjay Shah QA and Regulatory Engineer IMRIS Inc. 100-1370 Sony Place WINNIPEG MANITOBA R3T 1N5 CANADA .
Re: K121997
Trade/Device Name: IMRIS Oncology Package Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH and MOS Dated: July 4, 2012 Received: July 9, 2012
Dear Mr. Shah:
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 class II (Special Controls), it may be subject to such 11 your dowled to the birting major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 r lease of actived and I Drimination that your device complies with other requirements of the Act that 1 Dr Has Intact a and regulations administered by other Federal agencies. You must or any I vatual the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice mourements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket will anow you to oogin finding of substantial equivalence of your device to a legally marketed nothleation. THE FDTS imanly of tication 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-GFR-Parts 801-and If you desire specific advice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5-150. Thise, productions are veganding the reporting the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Tou may other bates generational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | <121997 |
|---|---|
| --------------------------- | --------- |
. Device. Name: IMRIS Oncology Package
-Indications for Use: -
The IMRIS Oncology package uses the IMRISneuro family of Intra-operative MRI systems/Siemens MAGNETOM MR systems indicated for use as a diagnostic imaging device that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that display the internal structure and / or function of the entire body, including, but not limited to head, neck, and pelvis regions. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The IMRIS Oncology Package provides an additional patient tabletop for IMRIS MR systems /Siemens MAGNETOM that allows patients to be imaged on a flat surface. The flat patient surface enables IMRIS MR system/Siemens MAGNETOM to acquire images in patient positions similar to other modalities that also utilize a flat patient surface such as X-ray, CT, PET and radiation therapy.
The IMRIS MR systems/Siemens MAGNETOM MR Systems with IMRIS Oncology Package may also be used with MR safe/MR conditional patient positioning and immobilization accessories to assist in obtaining consistent patient positions throughout multiple imaging sessions.
Prescription Use ---------X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K121997
IMRIS Oncology package 510(k) Premarket Notification
Page 1 of 1
§ 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.