(58 days)
No
The summary describes a standard MR scanner and its hardware components, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
No.
The device is described as a "magnetic resonance diagnostic device" used to produce images and/or spectra that assist in diagnosis, not directly treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "produces ... images ... that may assist in diagnosis."
No
The device description explicitly states it is a "3 Tesla MR scanner based on a superconducting magnet" and lists various hardware components.
Based on the provided information, the MAGNETOM Verio is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device "produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra" and "displays the internal structure and / or function of the head, body, or extremities." This describes an in vivo diagnostic imaging device, meaning it is used to examine the inside of a living body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro). The MAGNETOM Verio does not perform tests on such samples.
- Device Description: The description details a "3 Tesla MR scanner based on a superconducting magnet," which is consistent with an in vivo imaging system, not an IVD.
- Input Imaging Modality: The input modality is "Magnetic Resonance," which is an in vivo imaging technique.
Therefore, the MAGNETOM Verio is an in vivo diagnostic imaging device, specifically a Magnetic Resonance Diagnostic Device (MRDD), and not an IVD.
N/A
Intended Use / Indications for Use
The MAGNETOM Verio 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. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Verio may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR-safe biopsy needles.
Product codes
LNH
Device Description
The MAGNETOM Verio comes with I-class and T-class releases based on syngo MR B15B. It is a 3 Tesla MR scanner based on a superconducting magnet. It consists of the same types of hardware (with a modified magnet, gradient coil and RF body coil) that are currently available with the MAGNETOM Trio a Tim system including Matrix Coils and Total Imaging Matrix (Tim) technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance diagnostic device (MRDD)
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)
Performance measurements have been done on MAGNETOM Verio and MAGNETOM Trio a Tim System to show that the performance of the MAGNETOM Verio is equivalent with respect to the predicate device MAGNETOM Trio a Tim System. This will assure that the performance of MAGNETOM Verio is substantially equivalent with respect to the currently available MAGNETOM Trio a Tim System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Section 5: 510(k) Summary
5 510(k) Summary
001 1 0 2007
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 Verio | |
| | Classification Name:
CFR Code:
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
Section 5: 510(k) Summary
II. Safety and Effectiveness Information Supporting Substantial Equivalence.
Intended Use
The MAGNETOM Verio 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. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Verio may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR-safe biopsy needles.
Device Description
The MAGNETOM Verio comes with I-class and T-class releases based on syngo MR B15B. It is a 3 Tesla MR scanner based on a superconducting magnet. It consists of the same types of hardware (with a modified magnet, gradient coil and RF body coil) that are currently available with the MAGNETOM Trio a Tim system including Matrix Coils and Total Imaging Matrix (Tim) technology.
Substantial Equivalence
The system is substantially equivalent to the following cleared medical devices:
| Predicate Device Name | FDA Clearance
Number | FDA Clearance Date |
|------------------------------------------|-------------------------|--------------------|
| Siemens 3T MAGNETOM Trio a
Tim System | K050200 | Feb 28, 2005 |
| software syngo MR B15 (VB15A) | K062454 | Nov 3, 2006 |
2
General Safety and Effectiveness Concerns:
Operation of the MAGNETOM Verio is substantially equivalent to the commercially available MAGNETOM 3 T Trio a Tim System.
As specified in the FDA guidance document "Guidance for the Submission Of Premarket Notifications for Magnetic Resonance Devices" the following measurements of performance and safety data have been performed following National Electrical Manufacturing Association (NEMA) or equivalent IEC and ISO standards.
Safety
Static Field Strength Acoustic Noise dB/dt RF Heating Biocompatibility
Performance
Signal-to-Noise Ratio Geometric Distortion Image Uniformity Slice Thickness Spatial Resolution
The MAGNETOM Verio will conform to the measurement of safety parameters to the international IEC, ISO and NEMA standards for safety issues with Magnetic Resonance Imaging Diagnostic Devices.
Furthermore performance measurements have been done on MAGNETOM Verio and MAGNETOM Trio a Tim System to show that the performance of the MAGNETOM Verio is equivalent with respect to the predicate device MAGNETOM Trio a Tim System.
This will assure that the performance of MAGNETOM Verio is substantially equivalent with respect to the currently available MAGNETOM Trio a Tim System.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three wavy lines forming the body and head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
007 @ 2007
Ms. Judy Campbell Regulatory Technical Specialist Siemens Medical Solutions USA. Inc. Corporate Headquarters 51 Valley Stream Parkway MALVERN PA 19355
Re: K072237
Trade/Device Name: MAGNETOM Verio Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: August 8, 2007 Received: August 13, 2007
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, 1796, 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 (PMA), 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.
4
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.
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 to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 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
4 Indications for Use Statement
510(k) Number (if known)
Device Name: MAGNETOM Verio
Indications for Use:
The MAGNETOM Verio 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. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Verio may also be used for imaging during interventional procedures when 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 of Reproductive, Abdomina Radiological Devic 510(k) Number