(59 days)
Not Found
Not Found
No
The summary describes a standard MRI system and does not mention any AI or ML capabilities.
No.
The device is described as a "diagnostic imaging device" used to produce images for "determining diagnosis," not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Trio system is indicated for use as a diagnostic imaging device."
No
The device description clearly states it is a "whole body scanner" and describes the physical process of magnetic resonance imaging, indicating it is a hardware device.
Based on the provided information, the MAGNETOM Trio system is not an IVD (In Vitro Diagnostic).
Here's why:
- 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.
- MAGNETOM Trio function: The description clearly states that the MAGNETOM Trio system is a "whole body scanner" that produces images of the "internal structures of the head and whole body" using magnetic resonance. This is an in vivo diagnostic imaging technique, meaning it is performed on a living organism.
The device operates by directly interacting with the patient's body to generate images, rather than analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The MAGNETOM Trio system is a whole body scanner designed to support higher resolution imaging and shorter scan times. The Trio system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head and whole body. The images produced by the Trio system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin echo time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The MAGNETOM Trio system is a whole body scanner designed to support higher resolution imaging and shorter scan times. The Trio system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head and whole body. The images produced by the Trio system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin echo time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
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)
Laboratory 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.
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.
The MAGNETOM Trio System is substantially equivalent to both the MAGNETOM 3.0 T Allegra Dedicated Head only System and GE's Body Imaging Coil for 3.0T Signa VH/I system.
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
1101 3586
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 Systems, Inc. | |||||
| 186 Wood Avenue South | ||||||
| Iselin, N.J. 08830 | ||||||
| Registration Number: | 2240869 | |||||
| Contact Person: | Mr. Jamie Yieh | |||||
| Technical Specialist, Regulatory Affairs | ||||||
| Phone: (732) 321-4625 | ||||||
| Fax: (732) 321-4841 | ||||||
| Email: jamie.yieh@siemens.com | ||||||
| Date of Summary Preparation: | 10/29/01 | |||||
| Device Name: | ||||||
| •Trade Name: | MAGNETOM Trio System | |||||
| •Classification Name: | Magnetic Resonance Diagnostic Device, CFR § | |||||
| •Classification: | Class II | |||||
| •Performance Standards: | None established under Section 514 the Food, Drug, and Act. |
892.1000
Cosmetic
1
II. Safety and Effectiveness Information Supporting Substantial Equivalence.
· Device Description:
• Intended Use
The MAGNETOM Trio system is a whole body scanner designed to support higher resolution imaging and shorter scan times. The Trio system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head and whole body. The images produced by the Trio system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin echo time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
· Technological Characteristics
The MAGNETOM Trio System is substantially equivalent to both the MAGNETOM 3.0 T Allegra Dedicated Head only System and GE's Body Imaging Coil for 3.0T Signa VH/I system.
· General Safety and Effectiveness Concerns:
Operation of the MAGNETOM Trio System is substantially equivalent to the commercially available MAGNETOM 1.5 T Sonata System and 3.0 T Dedicated Head Only Allegra System. The following are the safety parameter with action levels:
- Maximum Static Field ●
- Rate of Change of Magnetic Field ●
- RF Power Deposition .
- . Acoustic Noise Levels
and performance levels
- Specification Volume .
- Signal to Noise ●
- Image Uniformity .
- Geometric Distortion .
- Slice Profile, Thickness and Gap .
- High Contrast Spatial Resolution .
specified by the FDA guidance document for MR Diagnostic Devices were evaluated within this notification. The increase in static magnetic field of the system will affect the maximum static field and acoustic noise level, as well as certain performance levels with the system. However, the new levels are not significantly changed and, in the case of safety, parameters remain below the level of concern.
2
• Substantial Equivalence:
Laboratory 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.
3
Image /page/3/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three overlapping human profiles facing to the right. The profiles are arranged in a way that suggests unity and collaboration.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 8 2001
Mr. Jamie Yieh Technical Specialist, Regulatory Affairs Siemens Medical Systems, Inc. 186 Wood Avenue South ISELIN NJ 08830
Re: K013586
Trade/Device Name: Magnetom Trio System Magnetic resonance imaging system Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: October 29, 2001 Received: October 30, 2001
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
4
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
5
510(k) Number (if known) 人のノ 35 86
MAGNETOM Trio System Device Name:
Indications for Use:
The MAGNETOM Trio system is a whole body scanner designed to support higher resolution imaging and shorter scan times. The Trio system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head and whole body. The images produced by the Trio system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin echo time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
(please do not write below this line- continue on another page if needed)
| Concurrence of CDRH, Office of Device Evaluation | |
|---|---|
| Prescription Use | ✓ |
| OR | |
| Over-The-Counter Use |
cun broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices Ko13586
510(k) Number.