(23 days)
Not Found
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard MRI technology and image interpretation by a physician.
No
The device is described as a "diagnostic imaging device" used to produce images for determining a diagnosis, not for treating a condition.
Yes
The document explicitly states that the device is "indicated for use as diagnostic imaging device" and that the images it produces can "be useful in determining a diagnosis."
No
The device description explicitly states it is a "whole body scanner" with a "Permanent magnet," indicating it is a hardware device, not software only.
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 outside of the body.
- Device Function: The description clearly states the MAGNETOM OPEN viva is a "whole body scanner" that produces images of the "internal structures of the head or body." This is an in vivo (within the living body) imaging device.
- Method of Operation: It uses magnetic resonance to create images based on the properties of protons within the body. This is a physical imaging technique, not a chemical or biological test performed on a sample.
The device is a medical imaging device used for diagnosis, but it operates by scanning the patient directly, not by analyzing a sample taken from the patient.
N/A
Intended Use / Indications for Use
The MAGNETOM OPEN viva with the Permanent magnet is an open, whole body scanner. The MAGNETOM Open Viva with the Permanent magnet is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the MAGNETOM OPEN with the permanent magnet reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
90 LNH
Device Description
The MAGNETOM OPEN viva with the Permanent magnet is an open, whole body scanner.
The MAGNETOM OPEN viva with the new Permanent Magnet is substantially equivalent to the currently available MAGNETOM OPEN viva System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
internal structures of the head or body
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)
Laboratory testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.
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.
Not Found
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
K99 4316
510 (k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
I. General Information.
Establishment:
-
Address: Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, N.J. 08830
Registration Number: 2240869 -
Contact Person: Mr. Jamie Yieh Technical Specialist, Regulatory Submissions Phone: (732) 321-4625 Fax: (732) 321-4841
Date of Summary Preparation: 12/21/99
Device Name:
- Trade Name: Magnetom Open Viva with Permanent Magnet
- Classification Name: Magnetic Resonance Diagnostic Device, CFR & 892.1000
- · Classification: Class II
- · Performance Standards: None established under Section 514 the Food, Drug, and Cosmetic Act.
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II. Safety and Effectiveness Information Supporting Substantial Equivalence.
• Device Description:
• Intended Use
The MAGNETOM OPEN viva with the Permanent magnet is an open, whole body scanner. The MAGNETOM Open Viva with the Permanent magnet is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the MAGNETOM OPEN with the permanent magnet reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
· Technological Characteristics
The MAGNETOM OPEN viva with the new Permanent Magnet is substantially equivalent to the currently available MAGNETOM OPEN viva System.
· General Safety and Effectiveness Concerns:
Operation of the MAGNETOM OPEN viva with the new Permanent Magnet is substantially equivalent to standard operation of the MAGNETOM OPEN viva System. The following are the safety parameter with action levels:
- Maximum Static Field ●
- . Rate of Change of Magnetic Field
- RF Power Deposition .
- . Acoustic Noise Levels
and performance levels
- . Specification Volume
- . Signal to Noise
- Image Uniformity .
- . Geometric Distortion
- . Slice Profile, Thickness and Gap
- . High Contrast Spatial Resolution
specified by the FDA guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification.
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• Substantial Equivalence:
Laboratory testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The text is in all caps and is in a sans-serif font. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 2000
Jamie Yieh Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
Re:
K994316 Magnetom Open Viva with Permanent Magnet Dated: December 21, 1999 Received: December 22, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Yieh:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, 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 vour 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sinceraty yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) _ 1943 ملا
Device Name: Magnetom Open viva
Indications for Use:
The MAGNETOM OPEN viva with the Permanent magnet is an open, whole body scanner. The MAGNETOM Open Viva with the Permanent magnet is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the MAGNETOM OPEN with the permanent magnet reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
(please do not write below this line- continue on another page if needed)
OR
Concurrence of CDRH, Office of Device Evaluation
Prescription Use
Over-The-Counter Use
David A. Segner
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT and Radiological Devic 510(k) Number