(33 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on traditional MR hardware and technology.
No
The device is described as a "magnetic resonance diagnostic device (MRDD)" and its purpose is to "assist in diagnosis" by producing images or spectra, not to treat conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a magnetic resonance diagnostic device (MRDD)" and that the images and/or spectra "may assist in diagnosis."
No
The device description explicitly states it is a "1.5 T closed superconducting magnet designed scanner" and lists various hardware components, indicating it is a physical medical device, not software-only.
No, the MAGNETOM Essenza is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue samples, etc. The tests are performed in vitro (outside the body).
- The MAGNETOM Essenza is a magnetic resonance diagnostic device (MRDD). It produces images and/or spectra of the internal structure and/or function of the head, body, or extremities directly within the patient. This is an in vivo (within the body) diagnostic method.
The description clearly states that the device is used to image the internal structure and function of the body, not to test samples taken from the body.
N/A
Intended Use / Indications for Use
The MAGNETOM Essenza is indicated for use as magnetic resonance diagnostic devices (MRDD) that produces 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. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
The MAGNETOM Essenza 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 Essenza System is a 1.5 T closed superconducting magnet designed scanner. It consists of the same types of hardware (with a modified gradient coil, RF body resonator and magnet) that are currently available with the MAGNETOM Avanto Systems, including Matrix Coils and Total Imaging Matrix (Tim) Technolgy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
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)
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
K07/925
Section 5: 510(k) Summary
5 510(k) Summary
AUG 1 4 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 Mindit Magnetic Resonance Ltd.
Siemens MRI Center,
Gaoxin C. Ave. 2nd
Hi-Tech Industrial Park,
ShenZhen 518057, PR. China |
| Registration Number | 3004754211 |
| 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 Essenza
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
Section 5: 510(k) Summary
II. Safety and Effectiveness Information Supporting Substantial Equivalence.
Intended Use
The MAGNETOM Essenza is indicated for use as magnetic resonance diagnostic devices (MRDD) that produces 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. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
The MAGNETOM Essenza 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 Essenza System is a 1.5 T closed superconducting magnet designed scanner. It consists of the same types of hardware (with a modified gradient coil, RF body resonator and magnet) that are currently available with the MAGNETOM Avanto Systems, including Matrix Coils and Total Imaging Matrix (Tim) Technolgy.
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 | Oct 16, 2003 |
| Software syngo MR VB15 | K062454 | Nov 3, 2006 |
| Siemens MAGNETOM 1.5 T
Symphony (MAGNETOM Project 047) | K971684 | Aug 5, 1997 |
General Safety and Effectiveness Concerns:
The MAGNETOM Essenza 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 MAGNETOM Symphony 1.5 T systems.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Blvd., Rockville MD 20850. The text is in a simple, sans-serif font and is easy to read. The image is likely a scan or photograph of a document.
AUG 1 4 2007
Ms. Judith Campbell Regulatory Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway MALVERN PA 19355
Re: K071925
Trade/Device Name: MAGNETOM Essenza Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: July 11, 2007 Received: July 12, 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, 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.
Image /page/2/Picture/9 description: The image is a circular seal with the text "1906-2006" at the top. The letters "FDA" are in the center of the seal in a bold, sans-serif font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The seal appears to be a commemorative emblem for the centennial anniversary of the FDA.
wing and Oremoting O's
3
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4 Indications for Use Statement
510(k) Number (if known)_ Kひフ/ 9 2 5
Device Name: MAGNETOM Essenza
Indications for Use:
The MAGNETOM Essenza 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 Essenza may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR-safe biops y needles.
(please do not write below this line- continue on another page if needed)
| Concurrence of CDRH, Office of Device Evaluation | |
|---|---|
| -------------------------------------------------- | -- |
Prescription Use
Over-The-Counter Use
J.L. Hanz
(Division Sign-Off)
OR
of Reproductive. Ab