(44 days)
Not Found
No
The document does not mention AI, ML, or any related terms, and the description focuses on hardware modifications and standard MRI imaging principles.
No
The device is described as a "diagnostic imaging device" whose images "provide information that can be useful in determining a diagnosis." It is not described as treating or curing a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the MAGNETOM Rhapsody system is "indicated for use as a diagnostic imaging device."
No
The device description explicitly states it is a "1.0 T open superconducting magnet designed scanner" and consists of "hardware," indicating it is a physical medical device, not software-only.
Based on the provided information, this device 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.
- Device Function: The MAGNETOM Rhapsody system is a diagnostic imaging device that uses magnetic resonance to produce images of the internal structures of the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for producing images of internal structures and organs for diagnostic purposes, interpreted by a trained physician. This is a form of in vivo (within the living body) diagnostic imaging.
Therefore, the MAGNETOM Rhapsody system falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MAGNETOM Rhapsody system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The MAGNETOM Rhapsody system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Rhapsody 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), spinspin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Due to the 'open' design of the system, the Rhapsody may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The Modified MAGNETOM Rhapsody System is a 1.0 T open superconducting magnet designed scanner. It consists of the same types of hardware (with a modified SAFE designed bearing) in the currently available MAGNETOM Rhapsody systems. These original systems were cleared under premarket notification K003628.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems.
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): 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.
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.
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Ko 2 05 73
2 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.
General Information. I.
Establishment:
Address:
Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, N.J. 08830
2240869 Registration Number:
- Contact Person: Mr. Jamie Yieh Technical Specialist, Regulatory Affairs (732) 321-4625 (732) 321-4841
Date of Summary Preparation:
January 25, 2002
Device Name:
· Trade Name: Modified MAGNETOM Rhapsody System
· 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.
1
II. Safety and Effectiveness Information Supporting Substantial Equivalence.
· Device Description:
· Intended Use
The MAGNETOM Rhapsody system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The Rhapsody system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, system is marouted for asges of the internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Rhapsody 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 the minge upportation of thow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Due to the 'open' design of the system, the Rhapsody may also be used for Due to the 'open' design of tall procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.
· Technological Characteristics
The Modified MAGNETOM Rhapsody System is a 1.0 T open superconducting magnet designed scanner. It consists of the same types of hardware (with a modified SAFE designed bearing in the currently available MAGNETOM Rhapsody systems. These original systems were cleared under premarket notification K003628.
· General Safety and Effectiveness Concerns:
Operation of the Modified MAGNETOM Rhapsody System is substantially equivalent to the commercially available MAGNETOM Rhapsody 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 that will be operation The modified MAGNETOM Rhapsody will conform to the FDA recognized
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NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM Rhapsody system.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on a circular seal. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2002
Mr. Jamie Yieh Technical Specialist, Regulatory Affairs Siemens Medical Solutions USA, Inc. 186 Wood Avenue South ISELIN NJ 08830
Re: K020573
Trade/Device Name: Modification to Magnetom Rhapsody System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: January 25, 2002 Received: January 28, 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. Iisting 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/dsmaldsmamain.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1 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) KC 2 0573
Modified MAGNETOM Rhapsody System Device Name:
Indications for Use:
The MAGNETOM Rhapsody system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The MAGNETOM Rhapsody system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the entire body, including, but not limited to, the musculoskeletal, vascular, cardiac, and neuro systems. The images produced by the Rhapsody 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), spinspin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Due to the 'open' design of the system, the Rhapsody may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.
(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 | |
| (Division Sign-Off) | |||
| Division of Reproductive, Abdominal, | |||
| and Radiological Devices | |||
| 510(k) Number | K020753 |