(21 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts in the intended use, device description, or other sections.
No
The device is described as a diagnostic device that produces images to assist in diagnosis, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly 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 "designed scanner" and consists of "hardware that are currently available with the MAGNETOM Avanto and Symphony systems," indicating it is a hardware device.
No, 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. They are used to analyze these samples outside of the body.
- Device Function: The "MAGNETOM Symphony a Tim System" is a Magnetic Resonance (MR) imaging device. It produces images and/or spectra of the internal structure and function of the body directly on the patient. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's a "magnetic resonance diagnostic device (MRDD)" that produces images and spectra of the head, body, or extremities. This is consistent with in-vivo imaging, not in-vitro testing.
Therefore, based on the provided information, the "MAGNETOM Symphony a Tim System" is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MAGNETOM Symphony a Tim System is intended for use as a magnetic resonance The MANDI on 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 Symphony 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.
The "MAGNETOM Symphony 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 Symphony 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
Device Deseripati designed scanner. It consists of the same types of hardware that are currently available with the MAGNETOM Avanto and Symphony 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 This summary of 910(R) barry and 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 Symphony 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.
Classification:
CONFIDENTIAL
1
III. Safety and Effectiveness Information Supporting Substantial Equivalence.
Intended Use
The MAGNETOM Symphony a Tim System is intended for use as a magnetic resonance The MANDI on 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 Symphony 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
Device Deseripati designed scanner. It consists of the same types of hardware that are currently available with the MAGNETOM Avanto and Symphony 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 | 10/16/03 |
| Siemens MAGNETOM 1.5 T Symphony | K971684 | 08/05/97 |
General Safety and Effectiveness Concerns:
Operation of the MAGNETOM Symphony a Tim System is substantially equivalent to the commercially available MAGNETOM 1.5 T Avanto System and 1.5 T Symphony System.
The MAGNETOM Symphony 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 Avanto and Symphony systems.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
FEB 1 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ana Ladino Technical Specialist, Regulatory Submissions Siemens Medical Solutions, USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355
Re: K050199 Trade/Device Name: MAGNETOM Symphony a Tim System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: January 26, 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 teviewed your becaren be (a) p.
above and have determined the device is substantially equivalent (for the indications for use stated in above and have decemininarketed predicate devices marketed in interstate commerce prior to the chelosure) to regary mannent date of the Medical Device Amendments, or to devices that have been May 20, 1 770, the Chactinent dato of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmen in accordantes internet approval application (PMA). You may, therefore, market the do not require approval of a promance appear. The Act. The general controls provisions of the Act uceries, subject to the generation, 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 n your de rice is classinia (coo acch additional controls. Existing major regulations affecting your Apploval), it may of bacycer to and Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA de roce but of total 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 lease be advised mat rest in 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 I cacan statues and regalative, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, moractice requirements as set forth in the quality systems (QS) (21 CFR Part 8017, good x20); and if applicable, the clectronic 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) This letter will anow you to begin hanceing of substantial equivalence of your device to a legally premarked notheation: The PDA maing of basisification 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 If you desire specific advice for your cerros of 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, picase note the regulation entitled, formation on your responsibilities under the Act from the 607.77). Tou may obtain outer general and Consumer Assistance at its toll-free number (800) DVISion of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsmadsmam.html
Sincerely yours,
Nancy 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
Koro199 510(k) Number (if known)
Device Name: MAGNETOM Symphony a Tim System
Indications for Use:
The "MAGNETOM Symphony 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 Symphony 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 Division Sinn-Of Division of Reproductive. Ab and Radiological Device 510(k) Number
Siemens 510(k) Premarket Notification MAGNETOM Symphony a Tim System
January 26, 2005
Page 14
CONFIDENTIAL