(56 days)
No
The document describes a standard MRI system and its intended use for diagnostic imaging. There is no mention of AI, ML, or any advanced image processing techniques that would suggest the use of such technologies. The focus is on image acquisition and display for interpretation by a trained physician.
No
The device is described as a magnetic resonance diagnostic device (MRDD) used to produce images and/or spectra that assist in diagnosis, rather than for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the MAGNETOM Systems are "magnetic resonance diagnostic devices (MRDD)". They produce images and/or spectra that, "when interpreted by a trained physician, yield information that may assist in diagnosis." This directly indicates its role in diagnosis.
No
The device description clearly states it is a "magnetic resonance diagnostic device (MRDD)" which produces images and spectra, indicating it is a hardware system (MRI machine) with associated software, not a standalone software device.
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 description clearly states that the MAGNETOM Systems are "magnetic resonance diagnostic devices (MRDD)" that produce images and/or spectra of the internal structure and/or function of the head, body, or extremities. This is an in vivo diagnostic method, meaning it is performed on a living organism.
- No Mention of Samples: There is no mention of the device analyzing samples taken from the body.
Therefore, the MAGNETOM Systems described are in vivo diagnostic devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The MAGNETOM Systems with the syngo MR2006A are 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 Espree" .
the "MAGNETOM Avanto" .
the "MAGNETOM Symphony a Tim System" .
the "MAGNETOM Trio a Tim System" .
may also be used for imaging during interventional procedures performed with MR may also be accords in room display and MR safe biopsy needles.
Product codes
LNH
Device Description
The MAGNETOM Systems with Software syngo MR2006A refers to a software and hardware upgrade (syngo MR2006A) for existing MAGNETOM Family systems, including the MAGNETOM 1.5 Telsa Avanto, MAGNETOM 1.5 Telsa Espree, MAGNETOM 1.5 Telsa Symphony a Tim System, and MAGNETOM 3 Telsa Trio a Tim System. The MRI systems themselves remain the same as described and cleared in previous premarket notifications. The new syngo MR2006A has no significant effect on the MR safety and performance parameters, and the systems will conform to NEMA Standards and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
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)
K032428, K041112, K050199, K050200
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
52164
OCT 4 - 2005 Section 1: 510(k) Summary
Section 1: 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 AG. Bereich Med
Henkestrasse 127
D-91052 Erlangen. Germany |
| Registration Number | 8010024 |
| 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 Systems with Software syngo MR2006A |
| Classification Name:
CFR Section:
Classification: | Magnetic Resonance Diagnostic Device
21 CFR § 892.1000
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 Systems with the syngo MR2006A are 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 syngo MR2006A (VB13A) software upgrade will be available for the following MAGNETOM Family systems:
- The MAGNETOM 1.5 Telsa Avanto system with syngo MR2004V was described in . premarket notification K032428 which received FDA clearance October 16, 2003.
- The MAGNETOM 1.5 Telsa Espree system with syngo MR2005E was described in . premarket notification K041112 which received FDA clearance July 21, 2004.
- The MAGNETOM 1.5 Telsa Symphony a Tim System with syngo MR2006T was . described in premarket notification K050199 which received FDA clearance February 18, 2005.
- The MAGNETOM 3 Telsa Trio a Tim System with syngo 2006T was described in . premarket notification K050200 which received FDA clearance February 28, 2005.
Siemens Medical Solutions, Inc., intends to offer a software and hardware upgrade syngo MR2006A. The indications for use will stay exactly the same, with respect to the previous software versions mentioned in the comparison matrix.
Substantial Equivalence
The systems 1.5 T MAGNETOM Espree, Avanto, Symphony a Tim System and the 3 T MAGNETOM Trio a Tim System with syngo MR2006A are substantially equivalent to the following cleared medical devices:
| Predicate Device Name | FDA Clearance
Number | FDA Clearance
Date |
|-------------------------------------------------|-------------------------|-----------------------|
| Siemens MAGNETOM 1.5 T Avanto | K032428 | 10/16/03 |
| Siemens MAGNETOM 1.5 T Espree | K041112 | July 21, 2004 |
| Siemens MAGNETOM 1.5 T
Symphony a Tim System | K050199 | February 18, 2005 |
| Siemens MAGNETOM 3 T Trio a Tim
System | K050200 | February 28, 2005 |
2
General Safety and Effectiveness Concerns:
The introduction of the new syngo MR2006A has no significant effect on the MR safety and performance parameters.
Siemens Medical Solutions is adding an upgrade in software and hardware to the currently available MAGNETOM Systems. The MRI systems are exactly the same as those described and cleared in the predicate device premarket notifications. Various safety and performance testing was completed; however the values are not significantly changed and, in the case of safety parameters remain below the level of concern.
The MAGNETOM Systems 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 systems.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Judith Campbell Technical Specialist Siemens Medical Solutions, USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355
Re: K052164 Trade/Device Name: MAGNETOM Systems with Software syngo MR 2006A Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 8, 2005 Received: August 9, 2005
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, 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.
OCT 4 - 2005
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter with and in Jours of substantial equivalence of your device to a legally prematics notification: "The PDF minenig site and thus, permits 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 If you desire specific acvice for your de received to 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 Also, prease note the regulation entired, formation on your responsibilities under the Act from the 807.77). Tournay oount outer general missanal 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/industry/support/index.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
Section 3: Indications for Use
Section 3: Indications for Use Statement
652164
Device Name:
| MAGNETOM Symphony a Tim System | 510(k) Number (if known) K050199 |
|---|---|
| MAGNETOM Trio a Tim System | 510(k) Number (if known) K050200 |
| MAGNETOM Espree | 510(k) Number (if known) K041112 |
| MAGNETOM Avanto | 510(k) Number (if known) K032428 |
Indications for Use:
- The "MAGNETOM Espree" .
- the "MAGNETOM Avanto" .
- the "MAGNETOM Symphony a Tim System" .
- the "MAGNETOM Trio a Tim System" .
is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces Is indicated for use as a magnete resolise cross sectional images, spectroscopic images and/or transverse, sagntail, coronal and come structure and/or function of the head, body, or specula, and that shoplays and interpreted by a trained physician, yield information that may assist in diagnosis.
- The "MAGNETOM Espree" .
- the "MAGNETOM Avanto" ●
- the "MAGNETOM Symphony a Tim System" .
- the "MAGNETOM Trio a Tim System" .
may also be used for imaging during interventional procedures performed with MR may also be accords 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 | ____________________ |
|---|---|
| ---------------------- | ---------------------- |
David A. Syverson
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K052164 |
|---|---|
| --------------- | ---------------------------------------------------------- |
Siemens 510(k) Premarket Notification
syngo MR 2006A
Page 12
CONFIDENTIAL