(13 days)
Not Found
No
The document describes a receive-only MRI coil and its intended use for standard imaging. There is no mention of AI, ML, or any image processing capabilities that would suggest the use of such technologies. The description focuses on the physical design and function of the coil.
No
The information provided states that the device is designed to "provide Magnetic Resonance Images" and that "these images yield information that can be useful in the determination of a diagnosis," indicating it is an imaging and diagnostic device, not a therapeutic one.
Yes
Explanation: The device is described as an "NMR device that produces images" which "when interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis." This clearly indicates its role in providing information for diagnostic purposes.
No
The device description explicitly states it is a "multi-element phased array, receive-only coil" with "coil elements and accessory electronics enclosed in a rigid plastic housing," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The QD Head Speeder with NV Speeder Attachment is a coil used with an MRI system. Its purpose is to receive magnetic resonance signals from the patient's body to create images. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to provide Magnetic Resonance Images of specific anatomical sites. These images are then interpreted by a trained physician for diagnosis. This is a form of in vivo (within the living body) imaging, not in vitro (in glass, or outside the body) testing.
Therefore, the device falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The QD Head Speeder with NV Speeder Attachment is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest in Magnetic Resonance Imaging Systems. The QD Head Speeder with NV Speeder Attachment is designed for use with the ExcelArt 1.5T MRI system manufactured by Toshiba Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.
The QD Head Speeder with NV Speeder Attachment is designed to provide Magnetic Resonance Images of the brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest. The QD Head Speeder with NV Speeder Attachment is designed for use with the ExcelArt 1.5 MRI system manufactured by Toshiba Medical Systems, Inc.
Anatomic Regions: brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 1.5T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
Product codes
90 MOS
Device Description
The QD Head Speeder with NV Speeder Attachment is a multi-element phased array, receive-only coil. The coil consists of three sections: a main coil base, a sliding head section, and a removable anterior coil section. The open, patient friendly design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest
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
K04 1487
SUMMARY OF SAFETY AND EFFECTIVENESS
| 1. Device Name : | Magnetic Resonance Imaging Accessory | QD Head Speeder with NV Speeder
Attachment | Comparison to predicate device or other 510(k)
cleared products |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Proprietary Name : | QD Head Speeder with NV Speeder Attachment | Intended Use: Imaging of the brain,
cervical spine, and soft tissue and
vasculature of the head, neck, and
upper chest. | -Similar to the Millennium 9000 Phased Array
Neurovascular Coil manufactured by USA
Instruments, Inc. (K001870)
-Similar to the Excalibur 9000 TotalSENSE™ Quad
Array Head Coil manufactured by USA
Instruments, Inc. (K022582) |
| 3. Classification : | Class II | Indications for Use: Identical to routine
MRI imaging. | -Similar to the Millennium 9000 Phased Array
Neurovascular Coil manufactured by USA
Instruments, Inc. (K001870)
-Similar to the Excalibur 9000 TotalSENSE™ Quad
Array Head Coil manufactured by USA
Instruments, Inc. (K022582) |
| 4. Establishment Registration #: | 1529041 | Coil Enclosure Material:
Flame-retardant Delrin-Acetal
Flame-retardant Polyurethane
Flame-retardant Vinyl Coated EVA
Foam
Flame-retardant Polycarbonate | -Similar to the Excalibur 9000 TotalSENSE™ Quad
Array Head Coil manufactured by USA
Instruments, Inc. (K022582)
-Similar to the Excalibur 9000 TotalSENSE™ Quad
Array Head Coil manufactured by USA
Instruments, Inc. (K022582)
-Similar to the Spirit III TotalSENSE™ Cardiac Coil
manufactured by USA Instruments, Inc. (K024187) |
| 5. Manufacture Facility Location: | USA Instruments, Inc.,
1515 Danner Drive
Aurora, Ohio 44202, USA
Telephone: 330-562-1000; Fax: 330-562-1422. | Coil Design: Receive-only phased
array coil. | -Similar to the Excalibur 9000 TotalSENSE™ Quad
Array Head Coil manufactured by USA
Instruments, Inc. (K022582) |
| 6. Performance Standard: | No applicable performance standards have been
issued under Section 514 of the Food, Drug and
Cosmetic Act. | Decoupling: Switching diode
decoupling. | -Similar to the Excalibur 9000 TotalSENSE™ Quad
Array Head Coil manufactured by USA
Instruments, Inc. (K022582) |
| 7. Intended Use: | The QD Head Speeder with NV Speeder
Attachment is a receive-only phased array RF coil,
used for obtaining diagnostic images of the brain,
cervical spine, and soft tissue and vasculature of
the head, neck, and upper chest in Magnetic
Resonance Imaging Systems. The QD Head
Speeder with NV Speeder Attachment is designed
for use with the ExcelArt 1.5T MRI system
manufactured by Toshiba Medical Systems, Inc. The
indications for use are the same as for standard MR
Imaging. | Prevention of RF Burns: Does not
transmit RF power; decoupling isolates
the coil elements from RF fields during
RF transmission; coil elements and
circuitry are enclosed in a non-
conductive housing. | -Similar to the Excalibur 9000 TotalSENSE™ Quad
Array Head Coil manufactured by USA
Instruments, Inc. (K022582) |
| 8. Device Description: | The QD Head Speeder with NV Speeder
Attachment is a multi-element phased array,
receive-only coil. The coil consists of three sections:
a main coil base, a sliding head section, and a
removable anterior coil section. The open, patient
friendly design minimizes claustrophobic effects and
maximizes patient comfort. The coil elements and
accessory electronics are enclosed in a rigid plastic
housing, which is fire rated and has a high impact
and tensile strength. | Radio Frequency Absorption: Coil is a
receive only coil and does not transmit
RF power. | -Similar to the Excalibur 9000 TotalSENSE™ Quad
Array Head Coil manufactured by USA
Instruments, Inc. (K022582) |
| Formation of Resonant Loop:
Decoupling isolates the coil elements
from RF fields during RF transmission;
length of cable and stiffness does not
permit looping. | -Similar to the Excalibur 9000 TotalSENSE™ Quad
Array Head Coil manufactured by USA
Instruments, Inc. (K022582) | | |
-
- Safety and Effectiveness
1
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 7 2004
Mr. James J. Wrenn Manager, QA and Regulatory Affairs USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K041487 Trade/Device Name: QD Head Speeder with NV Speeder Attachment Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 MOS Dated: June 2, 2004 Received: June 4, 2004
Dear Mr. Wrenn:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becally of the device is substantially equivalent (for the indications felerenced above and have actering marketed predicate devices marketed in interstate for use stated in the encrosary to regally to regally the Medical Device Amendments, or to commerce prof to May 20, 1976, the clordance with the provisions of the Federal Food, Drug, devices that have occh resulted in accere approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, therefore, market the Bet include requirements for annual registration, listing of general controls provisions of tactice, 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 If your device is classince (soo abore) and existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and t may be subject to such additional commons, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oods of reants concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri s issuality of our device complies with other requirements of the Act that I DA has made a decernmances that your is a ministered by other Federal agencies. You must comply of ally I ederal statures and regulations and but not limited to: registration and listing (21 CFR Part with an the Act 3 requirements, merculary of actice requirements as set forth in the 80 //, labeling (21 CFR Part 820); and if applicable, the electronic product quality systems (QU) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin nationing of substantial equivalence of your device to a legally premaired notification. The FDA mailing of casification 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 If you desire specific advice for your done of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the pro-Other of Complanoo at (2017) 221 Part 807.97) you may obtain. Other general by receive to premarked notified in (er the Act may be obtained from the Division of Small mormation on your responsional 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| 510(k) Number (if known): | K041487 |
|---|---|
| --------------------------- | --------- |
Device Name: QD Head Speeder with NV Speeder Attachment
Indications for Use: The QD Head Speeder with NV Speeder Attachment is designed to provide Magnetic Resonance Images of the brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest. The QD Head Speeder with NV Speeder Attachment is designed for use with the ExcelArt 1.5 MRI system manufactured by Toshiba Medical Systems, Inc.
Anatomic Regions: brain, cervical spine, and soft tissue and vasculature of the head, neck, and upper chest Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The 1.5T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | ✓ |
|---|---|
| OR | |
| Over-The-Counter Use | |
| (Optional Format 1-2-96) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K04487 |