(90 days)
SIEMENS MAGNETOM Vision, MAGNETOM Impact
Not Found
No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or algorithms that would typically indicate the presence of AI/ML. The description focuses on the core MRI technology and its intended use for general diagnostic imaging.
No
The device is described as a diagnostic imaging system, not one that provides therapy. Its intended use is for "general diagnostic use" and to "present images."
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for general diagnostic use."
No
The device description explicitly states it is a "whole body magnetic resonance imaging (MRI) system," which is a hardware 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 (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The SIEMENS MAGNETOM Project 024 is a Magnetic Resonance Imaging (MRI) system. MRI is an in vivo imaging technique, meaning it examines the body directly without taking specimens.
- Intended Use: The intended use is for "general diagnostic use" by presenting images and spectra reflecting the spatial distribution and magnetic resonance properties of nuclei within the body. This is consistent with an in vivo imaging device, not an IVD.
Therefore, based on the provided information, the SIEMENS MAGNETOM Project 024 is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Whole body magnetic resonance imaging.
The SIEMENS MAGNETOM Project 024 is a 1Tesla whole body magnetic resonance imaging (MRI) system intended for general diagnostic use. This MRI system will present images which reflect the spatial distribution and/or magnetic resonance spectra which are a function of the 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.
Product codes
90 LNH
Device Description
The SIEMENS MAGNETOM Project 024 is a 1.0T vhole body magnetic The SIEMILING MITONETON tern. The MAGNETOM Project 024 is the first resonalice innaging (MRL) byotic resonance imaging (MRI) systems. The meatber of a family of mag-e Project 024 is being introduced as a new system and as an upgrade to the commercially available MAGNETOM Impact system.
The MAGNETOM Project 024 system is a high field strength system. The new MAGNETOM system has a new compact design and a redesigned patient table and rf coil system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
SIEMENS MAGNETOM Vision, MAGNETOM Impact
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
SIEMENS
JUN - 5 1997
This summary of 510(k) safety and effectiveness information is being submitted in
t and and and 1 CLC 4 CLCL CLCL 1808 and 21 CER 807 92 This summary of 510(K) Safety and east of SMDA 1990 and 21 CFR 807.92.
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: | Ms. Kathleen Rutherford
Manager, Regulatory Submissions
(908) 321-4779
(908) 321-4841 |
| Date of Summary Preparation: | 3/06/97 |
| Device Name:
• Trade Name: | MAGNETOM Project 024 |
| • Classification Name: | Magnetic Resonance Diagnostic Device
CFR § 892.1000 |
| • Classification: | Class II |
| • Performance Standards: | None established under Section 514 of
the Food, Drug, and Cosmetic Act. |
II. Safety and Effectiveness Information Supporting Substantial Equivalence. Device Description:
The SIEMENS MAGNETOM Project 024 is a 1.0T vhole body magnetic The SIEMILING MITONETON tern. The MAGNETOM Project 024 is the first resonalice innaging (MRL) byotic resonance imaging (MRI) systems. The meatber of a family of mag-e
Project 024 is being introduced as a new system and as an upgrade to the commercially available MAGNETOM Impact system.
1
SIEMENS
Intended Use: Whole body magnetic resonance imaging.
Technological Characteristics:
The MAGNETOM Project 024 system is a high field strength system. The new MAGNETOM system has a new compact design and a redesigned patient table and rf coil system.
General Safety and Effectiveness Concerns:
The safety and performance characteristics for this system are within the scope of parameters cleared for market for the MAGNETOM Vision and MAGNETOM Impact systems. No additional safety concerns have been raised.
The device labeling for the Project 024 system will contain instructions for use, indications for use, precautions, cautions, contraindications, and warnings to the user.
Substantial Equivalence:
The MAGNETOM Project 024 system is substantially equivalent to the SIEMENS MAGNETOM Vision and MAGNETOM Impact magnetic resonance imaging systems.
Khtleen Rutherford / CAP
Kathleen M. Rutherford Manager, Regulatory Submissions Imaging Systems Group Siemens Medical Systems, Inc.
3/6/97
Date
Date
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard --Rockville MD 20850
JUN - 5 1997
Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
Re: K970852
MAGNETOM Project 024 (Numeris 3.5 Software) Dated: March 6, 1997 Received: March 7, 1997 .. Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Ms. Rutherford: 11
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in interstate commerce pror to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions egainst misbranding and adulteration.
If your device is classified (see above) into either class II (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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you might have under sections 51 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(t) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrl/dsmamain.html".
Sincerely yours.
William
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
SIEMENS
510(k) Number (if known)
Device Name: MAGNETOM Project 024
Indications for Use:
The SIEMENS MAGNETOM Project 024 is a 1Tesla whole body magnetic resonance imaging (MRI) system intended for general diagnostic use. This MRI system will present images which reflect the spatial distribution and/or magnetic resonance spectra which are a function of the 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.
(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
510(k) Number
Shmil C. Seymore
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological I
Siemens Medical Systems, Inc.
- Page 1 of 1 -
Imaging Systems Group
186 Wood Avenue South Iselin, NJ 08830
Tel: (908) 321-4500 (908) 494-2250