(31 days)
Not Found
No
The document describes a standard MRI system and does not mention any AI or ML capabilities in the intended use, device description, or other sections.
No.
The device is described as a "magnetic resonance diagnostic device" used for producing images to "assist in diagnosis," indicating a diagnostic rather than therapeutic purpose.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use as a magnetic resonance diagnostic device (MRDD)" and that the images/spectra "may assist in diagnosis."
No
The device description explicitly states it is a "3.0 T closed superconducting magnet whole body designed scanner" and consists of hardware components, indicating it is a hardware device with associated software, not a software-only medical device.
Based on the provided information, the MAGNETOM Trio a Tim System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "magnetic resonance diagnostic device (MRDD)" that produces images and/or spectra of the internal structure and/or function of the body. This is a description of an in vivo diagnostic imaging device, not a device used to examine specimens taken from the body (which is the definition of in vitro).
- Device Description: The description details a whole-body scanner with a superconducting magnet, consistent with an MRI machine used for imaging the inside of a living patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the MAGNETOM Trio a Tim System is an in vivo diagnostic imaging device.
N/A
Intended Use / Indications for Use
The MAGNETOM Trio a Tim System is intended for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays 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 Trio a Tim System may also be used for imaging during interventional procedures 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 Trio a Tim System is a 3.0 T closed superconducting magnet whole body designed scanner. It consists of the same types of hardware that are currently available with the MAGNETOM Trio and Avanto systems.
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)
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
12 510(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. Ana Ladino
Technical Specialist. Regulatory Submissions
51 Valley Stream Parkway
Malvern. PA 19355
Phone: (610)448-1785
Fax: (610) 448-1787 |
| Device Name | Trade Name: MAGNETOM Trio a Tim 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.
Indications for Use
The MAGNETOM Trio a Tim System is intended for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays 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 Trio a Tim System may also be used for imaging during interventional procedures performed with MR compatible devices such as in room display and MR safe biopsy needles.
Device Description
The MAGNETOM Trio a Tim System is a 3.0 T closed superconducting magnet whole body designed scanner. It consists of the same types of hardware that are currently available with the MAGNETOM Trio and Avanto systems.
Substantial Equivalence
The system is substantially equivalent to the following cleared medical devices:
| Predicate Device Name | FDA Clearance
Number | FDA Clearance Date |
|-------------------------------|-------------------------|--------------------|
| Siemens MAGNETOM 1.5 T Avanto | K032428 | October 16, 2003 |
| Siemens MAGNETOM 3.0 T Trio | K013586 | December 28, 2001 |
General Safety and Effectiveness Concerns:
Operation of the MAGNETOM Trio a Tim System is substantially equivalent to the commercially available MAGNETOM 3.0 T Trio System and 1.5 T Avanto System.
The MAGNETOM Trio a Tim System 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 Trio and Avanto systems.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird.
FEB 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ana Ladino Technical Specialist Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway MALVERN PA 19355
Re: K050200
Trade/Device Name: MAGNETOM Trio a Tim System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: January 25, 2005 Received: January 28, 2005
Dear Ms. Ladino:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leviewed your becalled by equivalent (for the indications for use stated in above and nave deceminearketed predicate devices marketed in interstate commerce prior to the enclosure) to tegally manelou produced Device Amendments, or to devices that have been May 20, 1770, the onlinement active and of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accondation warmarket approval application (PMA). You may, therefore, market the do not require approval of a promance of the Act. The general controls provisions of the Act device, subject to the general version, 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 If your device is other the (see and additional controls. Existing major regulations affecting your Apploval), It inay of our 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 I Tcase be advised that 1991 to issual your device complies with other requirements of the Act or any FTA has made a decemmation mad your were rederal agencies. You must comply with all the r cacral statues and regulation 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) (21 CFR Part 8017, good manakelif 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)
The same of the supplied of a line of a latestial againsteals This letter will allow you to begin market as walness of your device of your device to a legally
premarket notification. The FDA finding of substantial equise of your device premarket notification. The FDA Inding of substantial equiratelie of your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleased
on the regulation of the fillers for af Hearing numbers, based on the r If you desire specific advice for your device on but facemig regarities. (even 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, please note the regulation entitled, "Misoraniality of your responsibilities under the Act from the 807.97). You may obtain other general informations on your responsibility of the number (800)
Division of Small Manufacturers, International and Consumer Assistance at its t DAVIsion of Sman Man-6597 or at its Internet address 056-2011-01-11-01-12-2017-01-11 11:11:11 11-01-2017
Sincerely yours,
Nanay C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
3 Indications for Use Statement
510(k) Number (if known) _Ko So2 00
Device Name: MAGNETOM Trio a Tim System
Indications for Use:
The MAGNETOM Trio a Tim System is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays 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 Trio a Tim System may also be used for imaging during interventional procedures 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 | |
|---|---|---|---|---|
| David A. Legmann (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices | ||||
| 510(k) Number | K050200 |
Siemens 510(k) Premarket Notification MAGNETOM Trio a Tim System
January 25, 2005
CONFIDENTIAL