(27 days)
Not Found
No
The provided text describes a standard MRI system and coil, focusing on its imaging capabilities and equivalence to predicate devices. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the presence of such technology.
No
The device is described as a "diagnostic imaging device" used to produce images for diagnosis, not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is indicated for use as diagnostic imaging device."
No
The device description explicitly states it is a "whole body scanner" and mentions hardware components like a "6 Channel Body Coil," indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Function: The description clearly states that the MAGNETOM system is a whole body scanner that produces images of the internal structures of the body using magnetic resonance. This is an in vivo (within the living body) imaging technique, not an in vitro (outside the living body) examination of specimens.
- Intended Use: The intended use is to produce images that, when interpreted by a trained physician, provide information useful in determining a diagnosis. This is consistent with diagnostic imaging, not IVD testing.
The device operates by interacting with the patient's body directly to generate images, which is fundamentally different from analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The MAGNETOM system with the 6 Channel Body Coil is a whole body scanner. The MAGNETOM system with the 6 Channel Body Coil is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. The images produced by the MAGNETOM system with the 6 Channel Body Coil reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR properties that determine the image appearance are proton density; spin lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Product codes
90 MOS
Device Description
The MAGNETOM system with the 6 Channel Body Coil is a whole body scanner. The MAGNETOM system with the 6 Channel Body Coil is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. The images produced by the MAGNETOM system with the 6 Channel Body Coil reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR properties that determine the image appearance are proton density; spin lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
internal structures of the 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)
Laboratory and clinical testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.
The 6 Channel Body Coil was tested for SNR and Image uniformity and the results presented in this submission show that they are equivalent with the predicate devices described in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Signal to Noise, Image Uniformity
Predicate Device(s)
K023571 MAGNETOM systems
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
Appendix 11: 510(k) Summary
11 Appendix: 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
- I. General Information.
Establishment:
- Address: Siemens Medical Solutions, Inc. ● 186 Wood Avenue South Iselin, N.J. 08830
Registration Number: 2240869
Contact Person: Mr. Jamie Yieh Senior Technical Specialist, Regulatory Affairs Telephone: (732) 321-4625 Fax: (732) 321-4841 Email: jamie.yieh@siemens.com
Date of Summary Preparation:
October 23, 2002
Device Name:
•Trade Name: 6 Channel Body Coil
· Classification Name: Magnetic Resonance Diagnostic Device, CFR § 892.1000
•Classification: Class II
• Performance Standards: None established under Section 514 the Food, Drug, and Cosmetic Act.
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II. Safety and Effectiveness Information Supporting Substantial Equivalence.
· Device Description:
• Intended Use
The MAGNETOM system with the 6 Channel Body Coil is a whole body scanner. The MAGNETOM system with the 6 Channel Body Coil is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. The images produced by the MAGNETOM system with the 6 Channel Body Coil reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR properties that determine the image appearance are proton density; spin lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
· Technological Characteristics
The MAGNETOM systems with the new 6 Channel Body Coil is substantially equivalent to the predicate MAGNETOM systems.
· General Safety and Effectiveness Concerns:
Operation of the MAGNETOM Symphony/Sonata and Upgrades to Symphony/Sonata systems with the 6 Channel Body Coil is substantially equivalent to standard operation of the commercially available MAGNETOM Symphony/Sonata/Upgrades to Symphony/Sonata systems. The following safety parameter with action levels:
- -Maximum Static Field Strength
- Rate of Change in Magnetic Field -
- RF Power deposition -
- Acoustic Noise Levels -
and performance levels:
- Specification Volume -
- Signal to Noise -
- Image Uniformity -
- -Geometric distortion
- High contrast spatial resolution -
- Slice profile, thickness and gap -
specified by the FDA guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification. The 6 Channel Body Coil was tested for SNR and Image uniformity and the results
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presented in this submission show that they are equivalent with the predicate devices described in this submission.
• Substantial Equivalence:
Laboratory and clinical testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
NOV 20 2002
d and Drug Administration 200 Corporate Boulevard lockville MD 20850
Mr. Jamie Yieh Senior Technical Specialist, Regulatory Affairs . Siemens Medical Systems, Inc. 186 Wood Avenue South ISELIN NI 08830
Re: K023571
Trade/Device Name: 6 Channel Body Coil for MAGNETOM Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 MOS Dated: October 23, 2002 Received: October 24, 2002
Dear Mr. Yieh:
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.
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This letter will allow you to begin marketing your device as described in your 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 this 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" (21 CFR Part 807.97). 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
Page 2
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3 Appendix: Indications for Use Statement
In accordance with FDA requirements (as of 1/1/96), the indications for use statement is attached on a separate page.
510(k) Number (if known) _ K ( 2 - 3 5 7 /
Device Name: 6 Channel Body Coil for MAGNETOM systems
Indications for Use:
The MAGNETOM system with the 6 Channel Body Coil is a whole body scanner. The MAGNETOM system with the 6 Channel Body Coil is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. The images produced by the MAGNETOM system with the 6 Channel Body Coil reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR properties that determine the image appearance are proton density; spin lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
(please do not write below this line- continue on another page if needed)
Concurrence of CDRH, Office of Device
Evaluation
Prescription Use
Over-The-Counter Use__
(Division Sign-Off)
Division of Reproductive, Abdominal
SPECIAL 510(k)