(133 days)
Not Found
No
The description focuses on remote assistance and collaboration features, not AI/ML for image analysis or other tasks.
No
The "Intended Use / Indications for Use" states that the devices are indicated for use as "magnetic resonance diagnostic devices (MRDD)" to assist in diagnosis, not provide therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the devices are "indicated for use as magnetic resonance diagnostic devices (MRDD)".
No
The device is described as a "software option called syngo Expert—i" for existing MAGNETOM MRI systems. While it is a software component, it is explicitly tied to and operates on specific hardware (the MAGNETOM systems), which are themselves medical devices. The software enhances the functionality of the hardware rather than being a standalone software medical device.
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 is a "magnetic resonance diagnostic device (MRDD)" that produces images and/or spectra of the internal structure and/or function of the head, body, or extremities. These images and spectra are interpreted by a trained physician to assist in diagnosis.
- Nature of IVDs: IVDs are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.
- Input Modality: The input modality is Magnetic Resonance, which is an imaging technique, not a method for analyzing biological samples.
The device is a medical imaging system used for in-vivo diagnosis, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The following MAGNETOM systems:
MAGNETOM 1.5 T Avanto MAGNETOM 1.5 T Espree MAGNETOM 1.5 T Symphony a Tim System MAGNETOM 3.0 T Trio a Tim System
with syngo Expert—i option described in this premarket notification 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.
They may also be used for imaging during interventional procedures performed with MR compatible devices such as, in room display and MR safe biopsy needles.
Siemens Medical Solutions, Inc., intends to offer a software option called syngo Expert—i. The indications for use will stay exactly the same, with respect to the previous > oftware versions mentioned in the comparison matrix.
The above listed MAGNETOM systems are 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.
They 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)
LNH
Device Description
Siemens Medical Solutions, Inc., intends to offer a software option called syngo Expert—i. The indications for use will stay exactly the same, with respect to the previous > oftware versions mentioned in the comparison matrix.
The syngo Expert-i feature allows the local user of the MRI (e.g. tech) to get help and assistance from other personnel of the radiology department (e.g. other tech or physician) to perform scans faster and with better quality. For this purpose, a remote user within the local network of the MRI (i.e. the network of the radiology) can log onto the MR main or satellite console.
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, local user of the MRI (e.g. tech), other personnel of the radiology department (e.g. other tech or 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.
K032428, K041112, K050199, K050200, K970852, K971684, K993731, K003192, K013586
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
JAN I 3 2006 (052423 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 Medical Solutions
Henkestrasse 127
D91052 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 syngo Expert—i option |
| 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.
H. Safety and Effectiveness Information Supporting Substantial Equivalence.
Intended Use The following MAGNETOM systems:
MAGNETOM 1.5 T Avanto MAGNETOM 1.5 T Espree MAGNETOM 1.5 T Symphony a Tim System MAGNETOM 3.0 T Trio a Tim System
Siemens 510(k) Premarket Notiification 1 Syngo Expert-I Option for MAGNETOM Systerns CONFIDENTIAL
1
K05 2423
MAGNETOM 1.0 T Harmony MAGNETOM 1.5 T Symphony MAGNETOM 1.5 T Sonata MAGNETOM 0.2 T Concerto MAGNETOM 3.0 T Trio
with syngo Expert—i option described in this premarket notification 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.
They may also be used for imaging during interventional procedures performed with MR compatible devices such as, in room display and MR safe biopsy needles.
Siemens Medical Solutions, Inc., intends to offer a software option called syngo Expert—i. The indications for use will stay exactly the same, with respect to the previous > oftware versions mentioned in the comparison matrix.
Substantial Equivalence
Within the definition of the Safe Medical Devices Act of 1990, the
MAGNETOM 1.5 T Avanto MAGNETOM 1.5 T Esprec MAGNETOM 1.5 T Symphony a Tim System MAGNETOM 3.0 T Trio a Tim System MAGNETOM 1.0 T Harmony MAGNETOM 1.5 T Symphony MAGNETOM 1.5 T Sonata MAGNETOM 0.2 T Concerto MAGNETOM 3.0 T Trio
with syngo Expert-i Option are substantially equivalent to the following cleared medical devices:
2
Section 2: Required Forms and Documents
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| MAGNETOM 1.5 T Avanto | K032428 | October 16, 2003 |
| MAGNETOM 1.5 T Espree | K041112 | July 21, 2004 |
| MAGNETOM 1.5 T Symphony a Tim System | K050199 | February 18, 2005 |
| MAGNETOM 3.0 T Trio a Tim System | K050200 | February 28, 2005 |
| MAGNETOM 1.0 T Harmony | K970852 | June 5, 1997 |
| MAGNETOM 1.5 T Symphony | K971684 | August 5, 1997 |
| MAGNETOM 1.5 T Sonata | K993731 | December 23, 1999 |
| MAGNETOM 0.2 T Concerto | K003192 | December 21, 2000 |
| MAGNETOM 3.0 T Trio | K013586 | December 28, 2001 |
KOSZ
General Safety and Effectiveness Concerns:
The introduction of the syngo Expert—i Option has effect on the MR safety. Therefore a risk analysis has been performed including new safety measures to reduce the residual risks to an acceptable level.
The MRI systems are exactly the same as what was described and cleared in the predicate premarket notifications. Safety testing will be completed before commercial introduction to the market.
3
Image /page/3/Picture/1 description: The image shows a logo with a stylized eagle and text around it. The eagle is depicted with three curved lines forming its body and wings. The text is arranged in a circular pattern around the eagle, following the curve of the circle. The text is not fully legible, but it appears to be part of a government agency or organization's name.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 3 2006
Ms. Judith Campbell Technical Specialist, Regulatory Submissions Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355
Re: K052423
Trade/Device Name: MAGNETOM Systems with syngo Expert-i option Regulation Number: 21 CFR §892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: December 22, 2005 Received: December 30, 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.
4
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 (o 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 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 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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
5
Kos 2423 Section 3 - Indications for Use
| Device Name | FDA Clearance Number |
|---|---|
| MAGNETOM 1.5 T Avanto | K032428 |
| MAGNETOM 1.5 T Espree | K0411-12 |
| MAGNETOM 1.5 T Symphony a Tim System | K050199 |
| MAGNETOM 3.0 T Trio a Tim System | K050200 |
| MAGNETOM 1.0 T Harmony | K970852 |
| MAGNETOM 1.5 T Symphony | K971684 |
| MAGNETOM 1.5 T Sonata | K993731 |
| MAGNETOM 0.2 T Concerto | K003192 |
| MAGNETOM 3.0 T Trio | K013586 |
The above listed MAGNETOM systems are 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.
They 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 syngo Expert-i feature allows the local user of the MRI (e.g. tech) to get help and assistance from other personnel of the radiology department (e.g. other tech or physician) to perform scans faster and with better quality. For this purpose, a remote user within the local network of the MRI (i.e. the network of the radiology) can log onto the MR main or satellite console.
(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 Sign-Off) | |
|---|---|
| -- | ----------------------------------------------- |
| Siemens 510(k) Premarket Notification | Division of Reproductive, Abdominal, and Radiological Devices |
|---|---|
| Syngo Expert-I Option for MAGNETOM Systems | (k) Number K052473 CONFIDENTIAL |
Syngo Expert-I Option for MAGNETOM Systems(k) Number _