(79 days)
Not Found
No
The document does not mention AI, ML, or any related concepts in the intended use, device description, or other sections. The focus is on standard MR imaging capabilities.
No.
The indications for use state that the device is for diagnosis and to assist in interventional procedures, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" states that the device is a "magnetic resonance diagnostic device (MRDD)" and that the images/spectra "may assist in diagnosis."
No
The device description explicitly states it is a "whole body scanner," which is a hardware component. The intended use also describes producing images, which requires hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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. This is a description of an in vivo diagnostic device, meaning it is used to examine the body directly.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro).
- Device Description: The description of a "whole body scanner" further reinforces that it is used on a living patient, not on samples.
- Input Imaging Modality: Magnetic Resonance is an imaging technique applied to the body, not a method for analyzing samples.
Therefore, the MAGNETOM C! is a magnetic resonance diagnostic device used for in vivo imaging, not an in vitro diagnostic device.
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 (comma separated list FDA assigned to the subject device)
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.
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): 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.
0
K0411111
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 | Application is Progress (See Attachment 3) |
| 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 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, 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.
Substantial Equivalence
The system is substantially equivalent to the following cleared medical devices:
| 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 |
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. Specified by the FDA guidance document for MR Diagnostic Devices that will be evaluated, below are the safety parameter with the following levels:
Action Levels
- · Maximum Static Field
- Rate of Change of Magnetic Field
- · RF Power Deposition
- · Acoustic Noise Levels
Performance Levels
- · Specification Volume
- · Signal to Noise
- · Image Uniformity
- · Geometric Distortion
- · Slice Profile. Thickness and Gap
- High Contrast Spatial Resolution
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol. The logo is simple, clean, and easily recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 6 2004
Ms. Nealie Hartman Technical Specialist Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway MALVERN PA 19355
Re: K041111
Trade/Device Name: MAGNETOM C! Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: 90 LNH Dated: April 26 , 2004 Received: April 28, 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 (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.
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.
3
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 the 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" (21CFR Part 807.97) you may obtain. 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. Bugden
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
4
SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known) ___ K 0 4 1/ 1/
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, (WITDB) and irroges 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)
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- | -- |
Nancy C Bugdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K041111 |
|---|---|
| --------------- | --------- |
CONFIDENTIAL