(36 days)
No
The document describes a standard MRI system and its accessories, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No
The device is described as a "magnetic resonance diagnostic device" used to produce images that "may assist in diagnosis," not for therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the device is "indicated for use as magnetic resonance diagnostic devices (MRDD)" and that the images/spectra "when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description explicitly states it is a "whole body scanner" and mentions hardware components like coils and a foot switch, indicating it is a physical medical device system, not software-only.
Based on the provided information, the MAGNETOM C! is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device produces images and/or spectra of the internal structure and/or function of the head, body, or extremities. These images are then interpreted by a trained physician to assist in diagnosis. This describes an in vivo diagnostic process (examining the body directly), not an in vitro process (examining samples outside the body).
- Device Description: The description details a whole body scanner and various coils used for imaging the body. This aligns with an in vivo imaging device.
- Input Imaging Modality: The input modality is Magnetic Resonance, which is an in vivo imaging technique.
- Anatomical Site: The device is used on the head, body, or extremities, which are parts of the living organism.
- Performance Studies: The performance studies mentioned relate to image quality (Signal to Noise, Image Uniformity) and safety parameters of the imaging device itself, not the analysis of biological samples.
In vitro diagnostics involve testing samples taken from the body, such as blood, urine, or tissue, outside of the body to detect diseases or conditions. The MAGNETOM C! operates by scanning the body directly using magnetic fields and radio waves.
N/A
Intended Use / Indications for Use
The MAGNETOM C! is indicated for use as magnetic resonance diagnostic devices (MRDD) 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 head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM C! 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
90 LNH
Device Description
The MAGNETOM C! system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times, which is was described in premarket notification K041111 which received FDA clearance on July 16, 2004. Siemens further market the Body spine XL coil, Wrist Array coil with 4 channels, Cordless Coil, Breast Array coil, Breast biopsy device, MR guided procedure Package, In Room MRC, Foot switch and the software update for the existing MAGNETOM C! MR system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance
Anatomical Site
head, body, or extremities
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)
Operation of the MAGNETOM C! System is substantially equivalent to the commercially available MAGNETOM 0.2 T Concerto System and 1.0 T Harmony System. Below are the parameter specified by the FDA guidance document for MR Diagnostic Devices that will be evaluated with the following levels:
Performance Levels
- · Signal to Noise
- · Image Uniformity
The MAGNETOM C! will conform to the FDA recognized 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 Concerto and Harmony systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Section 2: 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.
I. General Information
| Establishment | Siemens Medical Solutions. Inc.
51 Valley Stream Parkway
Malvern. PA 19355 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 2240869 |
| Manufacturer | Siemens Mindit Magnetic Resonance Ltd.
R1-B1, Hi-Tech Industrial Park, Shennan Ave.
Shenzhen 518057
P.R. China |
| Registration Number | 9063112 |
| Contact Person | Ms. Nealie Hartman
Technical Specialist. Regulatory Submissions
51 Valley Stream Parkway E50
Malvern. PA 19355
Phone: (610) 448-1769
Fax: (610) 448-1787 |
| Device Name | Trade Name: MAGNETOM C! System
Classification Name: Magnetic Resonance Diagnostic Dev
CFR Code: 21 CFR § 892.1000
Classification: Class II |
Performance Standards
None established under Section 514 the Food, Drug and Cosmetic Act.
ce
CONFIDENTIAL
1
II. Safety and Effectiveness Information Supporting Substantial Equivalence.
Intended Use
The MAGNETOM C! is indicated for use as magnetic resonance diagnostic devices (MRDD) 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 head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM C! 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
Device Description
The MAGNETOM C! system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times, which is was described in premarket notification K041111 which received FDA clearance on July 16, 2004. Siemens further market the Body spine XL coil, Wrist Array coil with 4 channels, Cordless Coil, Breast Array coil, Breast biopsy device, MR guided procedure Package, In Room MRC, Foot switch and the software update for the existing MAGNETOM C! MR system.
Substantial Equivalence
Siemens believes that, within the meaning of the Safe Medical Device Act of 1990, the MAGNETOM C!, which is configured with a new Body spine XL Coil, Wrist Array Coil with 4 channels, Cordless Coil, Breast Array Coil, Breast Biopsy Device, MR Guided Procedure Package, In Room MRC, Foot switch and the software update, is substantially equivalent to the following cleared medical devices, which offers the same applications and handling:
| Predicate Device Name | FDA Clearance
Number | FDA Clearance
Date |
|---------------------------------|-------------------------|-----------------------|
| Siemens MAGNETOM 0.2 T Concerto | K003192 | 12/21/2000 |
| Siemens MAGNETOM 1.0 T Harmony | K970852 | 06/05/1997 |
| Siemens MAGNETOM 0.35 T C ! | K041111 | 07/16/2004 |
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General Safety and Effectiveness Concerns
Operation of the MAGNETOM C! System is substantially equivalent to the commercially available MAGNETOM 0.2 T Concerto System and 1.0 T Harmony System. Below are the parameter specified by the FDA guidance document for MR Diagnostic Devices that will be evaluated with the following levels:
Performance Levels
- · Signal to Noise
- · Image Uniformity
The MAGNETOM C! will conform to the FDA recognized 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 Concerto and Harmony systems.
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 2004
Ms. Nealie Hartman Technical Specialist, Regulatory Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway MALVERN PA 19355
Re: K043030
Trade/Device Name: 0.35 T MAGNETOM C! MR System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 LNH Dated: October 29, 2004 Received: November 3, 2004
Dear Ms. Hartman:
· 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 (Premarket, Approval}, it may be subject to such 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.
4
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 this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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
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SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known)_ K 04 3 03 0
Device Name: MAGNETOM C!
Indications for Use:
The MAGNETOM C! is indicated for use as magnetic resonance diagnostic devices (MRDD) 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 head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM C! 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)
OR
Concurrence of CDRH, Office of Device Evaluation
Prescription Use V
Over-The-Counter Use
Daniel R. Szyman
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________