(48 days)
No
The document describes hardware and software modifications to an existing MRI system, focusing on improved image quality and scan times. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The lack of information on training or test sets further supports the absence of AI/ML.
No
The device is indicated for diagnostic purposes (producing images to assist in diagnosis) and interventional procedures (imaging during procedures), not for treating conditions.
Yes
Explanation: 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 produced "when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description explicitly lists numerous hardware components that are being modified (RF Infra Structure, RF Signal Unit, Filter Plate, Gradient Amplifier, etc.), indicating it is a hardware system with a software update, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The MAGNETOM C! is a Magnetic Resonance (MR) system. It produces images of the internal structure and function of the body in vivo (within the living organism). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's a "magnetic resonance diagnostic device (MRDD)" that produces images of the head, body, or extremities. This is consistent with an imaging device, not an IVD.
Therefore, based on the provided information, the MAGNETOM C! is an imaging device, not an In Vitro Diagnostic.
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, and that display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images 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.
Disclaimer: Utility of contrast enhanced breast MRI for the detection of breast masses has not been documented and is thus not indicated.
Product codes
LNH, MOS
Device Description
The MAGNETOM C! system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times, which was described in premarket notification K043030 which received FDA clearance on December, 10, 2004. Siemens intends to modify the RF Infra Structure, RF Signal Unit, Filter Plate, Gradient Amplifier, Physiological Measurement Unit, Measurement and Reconstruction System, Magnet Temperature Unit, Patient Table Control, Power Distribution System, External Field Interference, Integrated Cooling System and software update for the existing MAGNETOM C! Magnetic Resonance System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Diagnostic Devices (MRDD)
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)
Not Found
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.
0
510(k) Summary 5
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.
l. General Information
| Establishment | Siemens Medical Solutions. Inc.
51 Valley Stream Parkway
Malvern. PA 19355 |
| --------------- | ---------------------------------------------------------------------------------- |
|---|
Registration Number 2240869
- Manufacturer Siemens Mindit Magnetic Resonance Ltd. Siemens MRI Center, Gaoxin C. Ave. 2nd Hi-Tech Industrial Park, ShenZhen 518057, PR. China
- Registration Number 3004754211
Contact Person Ms. Judy Campbell Technical Specialist. Regulatory Submissions 51 Valley Stream Parkway Malvern. PA 19355 Phone: (610)448-4918 Fax: (610) 448-1787
| Device Name | |
|---|---|
| Trade Name: | MAGNETOM C! System |
| Classification Name: | Magnetic Resonance Diagnostic Device |
| CFR Code: | 21 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.
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, and that display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images 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.
Disclaimer: Utility of contrast enhanced breast MRI for the detection of breast masses has not been documented and is thus not indicated.
Device Description
The MAGNETOM C! system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times, which was described in premarket notification K043030 which received FDA clearance on December, 10, 2004. Siemens intends to modify the RF Infra Structure, RF Signal Unit, Filter Plate, Gradient Amplifier, Physiological Measurement Unit, Measurement and Reconstruction System, Magnet Temperature Unit, Patient Table Control, Power Distribution System, External Field Interference, Integrated Cooling System and software update for the existing MAGNETOM C! Magnetic Resonance System.
Substantial Equivalence
Siemens believes that, within the meaning of the Safe Medical Device Act of 1990, the MAGNETOM C!, which is configured with modified hardware and software, 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 1.5T
ESSENZA | K071925 | 08/14/2007 |
| Siemens MAGETOM 0.35 T C ! | K043030 | 12/10/2004 |
2
General Safety and Effectiveness Concerns
Operation of the MAGNETOM C! System is substantially equivalent to the commercially available MAGNETOM C! (K043030) System and 1.5 T ESSENZA System (071925). Below are the parameters specified by the FDA guidance document for MR Diagnostic Devices that will be evaluated based on the modifications:
Performance Levels
- · Signal to Noise
- · Image Uniformity
- · Geometric Distortion
- · High Contrast Spatial Resolution
- · Slice Thickness
Safety Levels
None
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 C!( K043030) and MAGNETOM ESSENZA (K071925).
3
Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", indicating the department's name and national affiliation.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 01 2008
Ms. Judith Campbell Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355
Re: K082331
Trade/Device Name: MAGNETOM C! Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Codc: LNH and MOS Dated: August 11, 2008 Received: August 14, 2008
Dear Ms. Campbell:
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 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.
4
Page 2
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.
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
hoque An Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement 4
510(k) Number (if known)
Device Name: MAGNETOM C!
Indications for Use:
The MAGNETOM C! is indicated for use as maqnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images 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
Disclaimer: Utility of contrast enhanced breast MRI for the detection of breast masses has not been documented and is thus not indicated.
(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
tion Use
OR
(Division Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __