(51 days)
HRH-63-8 Head Array Coil, 558GE-64 Torso Array Coil
Not Found
No
The document describes receive-only coils for MRI imaging and mentions image processing techniques similar to computed tomography, but there is no mention of AI, ML, or related concepts.
No.
The device is described as an "imaging device" intended to "provide the physician with physiological and clinical information" and for "diagnosis determination," without any mention of treatment or therapy.
Yes
The device is described as providing "information that can be useful in diagnosis determination," indicating its role in the diagnostic process.
No
The device description explicitly states that the device is a "recieve-only multiple array device," which is a hardware component (a coil) used in MRI imaging. While image processing is mentioned, the core device being described is hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states this device is an imaging device (specifically, an MRI coil) used to produce images of the internal structure of the body non-invasively. It detects MR signals from within the body, not from a sample taken from the body.
- Intended Use: The intended use is to provide physiological and clinical information through imaging, which is then interpreted by a physician for diagnosis. This is distinct from analyzing a biological sample.
The device's function and intended use fall squarely within the realm of medical imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The OASIS Specialty Coils are receive-only devices that detects the MR signal used to produce transverse, coronal, sagittal, obligue, and/or curved crosssectional images that display the internal structure of the images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
The indications for use for the OASIS Specialty Coils are as follows:
- . The MR-RHC-150N, ECHELON RAPID Head Coil is a recieve-only multiple array device used for MRI imaging of the brain.
- The MR-RBC-150N, ECHELON RAPID Torso Coil is a recieve-only multiple . array device used for MRI imaging of the abdomen.
Indications for Use:
The MR-RBC-150N, ECHELON RAPID Torso Coil is a recieve-only multiple array device used for MRI imaging of the abdomen.
Indications for Use:
The MR-RHC-150N, ECHELON RAPID Head Coil is a recieve-only multiple array device used for MRI imaging of the brain ..
Product codes
MOS
Device Description
Function
The MR-RHC-150N, ECHELON RAPID Head Coil is a recieve-only multiple array device used for MRI imaging of the brain.
The MR-RBC-150N, ECHELON RAPID Torso Coil is a recieve-only multiple array device used for MRI imaging of the abdomen.
Scientific Concepts
Magnetic Resonance Imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This re-orientation process is characterized by two exponential relaxation times, called T1 and T2.
A RF emission or echo that can be measured accompanies these relaxation events. The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echoes by varying the RF excitation, applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.
Physical and Performance Characteristics
The MR-RHC-150N, ECHELON RAPID Head Coil is a receive-only device suitable for imaging the brain. The coil consists of 16 elements. The signal output of each element is independently processed by the MRI system to enhance performance.
The MR-RBC-150N, ECHELON RAPID Torso Coil is a receive-only device suitable for imaging the abdomen. The coil consists of 16 elements. The signal output of each element is independently processed by the MRI system to enhance performance.
Mentions image processing
Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
brain, abdomen
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
HRH-63-8 Head Array Coil, 558GE-64 Torso Array Coil
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
510(k) Summary
Submitter Information
| Submitter: | Hitachi Medical Systems America, Inc.
1959 Summit Commerce Park
Twinsburg, Ohio 44080-2371
ph: (330) 425-1313
fax: (330) 963-0749 | JUN 1 8 2008 |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Douglas J. Thistlethwaite | |
| Date: | April 25, 2008 | |
Device Name
| Classification Name: | Coil, magnetic resonance, specialty |
|---|---|
| Classification Number: | 90MOS |
| Trade/Proprietary Name: | ECHELON RAPID Head Coil |
| Predicate Device(s): | HRH-63-8 Head Array Coil |
| Classification Name: | Coil, magnetic resonance, specialty |
| Classification Number: | 90MOS |
| Trade/Proprietary Name: | ECHELON RAPID Torso Coil |
| Predicate Device(s): | 558GE-64 Torso Array Coil |
Device Intended Use
The MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The OASIS Specialty Coils are receive-only devices that detects the MR signal used to produce transverse, coronal, sagittal, obligue, and/or curved crosssectional images that display the internal structure of the images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
The indications for use for the OASIS Specialty Coils are as follows:
- . The MR-RHC-150N, ECHELON RAPID Head Coil is a recieve-only multiple array device used for MRI imaging of the brain.
- The MR-RBC-150N, ECHELON RAPID Torso Coil is a recieve-only multiple . array device used for MRI imaging of the abdomen.
1
Image /page/1/Picture/1 description: The image shows handwritten text on a white background. The text includes the identifier "K081198" at the top, followed by "Pg. 2 of 3" on the next line. The handwriting appears to be in black ink, and the text is slightly smudged.
Device Description
Function
The MR-RHC-150N, ECHELON RAPID Head Coil is a recieve-only multiple array device used for MRI imaging of the brain.
The MR-RBC-150N, ECHELON RAPID Torso Coil is a recieve-only multiple array device used for MRI imaging of the abdomen.
Scientific Concepts
Magnetic Resonance Imaging (MRI) is based on the fact that certain atomic nuclei have electromagnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in magnetic resonance imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can cause a re-orientation of the net magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and varies with the character of the proton and its adjacent molecular environment. This re-orientation process is characterized by two exponential relaxation times, called T1 and T2.
A RF emission or echo that can be measured accompanies these relaxation events. The emissions are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echoes by varying the RF excitation, applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.
Physical and Performance Characteristics
The MR-RHC-150N, ECHELON RAPID Head Coil is a receive-only device suitable for imaging the brain. The coil consists of 16 elements. The signal output of each element is independently processed by the MRI system to enhance performance.
The MR-RBC-150N, ECHELON RAPID Torso Coil is a receive-only device suitable for imaging the abdomen. The coil consists of 16 elements. The signal output of each element is independently processed by the MRI system to enhance performance.
2
Image /page/2/Picture/1 description: The image shows handwritten text on a white background. The text "K081198" is written on the top line, and "pg. 3 of 3" is written on the second line. The text appears to be a document identifier and page number.
Device Technological Characteristics
The technological characteristics of the ECHELON RAPID Head Coil and ECHELON RAPID Torso Coil are similar to the predicate devices as listed in Section 10 -Substantial Equivalence Discussion.
Conclusions
It is the opinion of Hitachi Medical Systems America, Inc. that the ECHELON RAPID Head Coil and ECHELON RAPID Torso Coil are substantially equivalent to the listed predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 8 2008
Mr. Doug Thistlethwaite Manager, Regulatory Affiars Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park TWINSBURG OH 44087
Re: K081198
Trade/Device Name: ECHELON RAPID Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: April 25, 2008 Received: April 28, 2008
Dear Mr. Thistlethwaite:
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 (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/odrb/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
510(k) Number (if K081198 known): ECHELON RAPID Torso Coil Device Name:
Indications for Use:
The MR-RBC-150N, ECHELON RAPID Torso Coil is a recieve-only multiple array device used for MRI imaging of the abdomen.
Prescription Use × AND/OR
Over-the-Counter Use
(21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Aomi M. Whang
(Division/Sign-Off) (Division/Sign-Olf)
Division of Reproductive, Abdominal, and Radiological Device 510(k) Number
6
| 510(k) Number (if known): | K081198 |
|---|---|
| Device Name: | ECHELON RAPID Head Coil |
Indications for Use:
The MR-RHC-150N, ECHELON RAPID Head Coil is a recieve-only multiple array device used for MRI imaging of the brain ..
Prescription Use × AND/OR
Over-the-Counter Use
(21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
i
Argu M. Whay
(Division Sign-Off)
Division of Reproductive. Abdominal. Radiological Devices 510(k) Number