← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K991724
# QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64 (K991724)
_Medical Advances, Inc. · MOS · Aug 2, 1999 · Radiology · SESE_
**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K991724
## Device Facts
- **Applicant:** Medical Advances, Inc.
- **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md)
- **Decision Date:** Aug 2, 1999
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.1000
- **Device Class:** Class 2
- **Review Panel:** Radiology
## Intended Use
Magnetic resonance imaging (MRI) of the knee, ankle, foot, and associated structures.
## Device Story
Model 473PH-64 Quadrature Lower Extremity Coil is an accessory for the Philips Gyroscan ACS-NT 1.5T MRI system. It functions as a radiofrequency receiver coil to capture magnetic resonance signals from the knee, ankle, and foot. The device enables 2D/3D imaging, including proton density, T1/T2 weighted imaging, time-of-flight, and phase contrast imaging. Used in clinical radiology settings by trained MRI technologists/radiologists. The coil improves signal-to-noise ratio and image quality for lower extremity diagnostics, aiding clinicians in visualizing anatomical structures for diagnostic purposes.
## Clinical Evidence
Bench testing only. No clinical data provided. Equivalence established through comparison of safety and imaging performance parameters against the base MRI system.
## Technological Characteristics
Quadrature radiofrequency receiver coil for 1.5T MRI. Materials comply with UL 94 (flammability). Safety standards include UL 2601-1 and IEC 601-1. Designed for integration with Philips Gyroscan ACS-NT 1.5T system. Passive hardware device; no software or active electronic processing components.
## Regulatory 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).
## Special Controls
*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.
## Reference Devices
- Philips Gyroscan ACS-NT 1.5T MRI System
## Submission Summary (Full Text)
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# K99724
## 510(k) Summary of Safety and Effectiveness
| Device Name | Model 473PH-64
Quadrature Lower Extremity Coil |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------|
| Applicability | Compatible with Philips Gyroscan ACS-NT 1.5T
MRI System |
| Reason for 510(k) | New device |
| Classification Name | Magnetic Resonance Diagnostic Device |
| Device Classification Panel | Radiology |
| Device Classification Number | 892.1000 |
| Product Code | 90LNH |
| Common Name | Magnetic Resonance Imaging Coil |
| Proprietary Name | Model 473PH-64
Quadrature Lower Extremity Coil |
| Establishment Registration Number | 2183683 |
| Address of MFG Facility | Medical Advances, Inc.
10437 Innovation Drive
Milwaukee, WI 53226 |
| Point of Contact | Thomas E. Tynes
Vice President - Operations
(414) 258-3808 Ext. 407 |
| Classification | Class II |
| Intended Uses | |
| Diagnostic Uses | 2D, 3D imaging, proton density, T1 and T2
weighted imaging. 2D, 3D time of flight, phase
contrast imaging. |
| Anatomic Regions | Knee, ankle and foot. |
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#### Standards
| Performance Standards | None Established under Section 514 | |
|----------------------------|------------------------------------|--------------------------------------------------------------------------|
| Voluntary Safety Standards | UL 2601-1 | Medical Electrical Equipment, Part
1: General Requirements for Safety |
| | UL 94 | Tests for Flammability of Plastic
Materials |
| | IEC 601-1 | General Safety Requirements for
Medical Electrical Equipment |
#### Overview
The Radiology Devices Panel considered potential concerns regarding the safe and effective operation of Magnetic Resonance Diagnostic Devices when they recommended reclassification to Class II on July 27, 1987. After reclassification, the FDA's Center for Devices and Radiological Health released a draft guidance document for the content and review of Magnetic Resonance Diagnostic Device premarket notification submissions that offered clarification of these concerns. The following is a summary of the information contained within this premarket notification that addresses these concerns:
The Philips Gyroscan ACS-NT 1.5T MRI System operated with the Medical Advances Quadrature Lower Extremity Coil is substantially equivalent to the same system operated without the Medical Advances Quadrature Lower Extremity Coil, within the Class II definition of Magnetic Resonance Diagnostic Device with respect to the safety parameter action levels:
#### Safety Parameters
| Maximum Static Magnetic Field: | No change |
|-----------------------------------------|-----------|
| Rate of Magnetic Field Strength Change: | No change |
| RF Power Deposition: | No change |
| Acoustic Noise Levels: | No change |
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### Imaging Performance Parameters
| Specification Volume: | No change |
|-----------------------------------|-----------|
| Signal-to-Noise Ratio: | No change |
| Image Uniformity: | No change |
| Geometric Distortion: | No change |
| Slice Thickness and Gap: | No change |
| High Contrast Spatial Resolution: | No change |
#### General Safety and Effectiveness Concerns
The device contains instructions for use. It includes indications for use, precautions, cautions, contraindications, warnings and quality assurance testing. This information assures safe and effective use of the device.
#### Substantial Equivalence Summary
The Philips Gyroscan ACS-NT 1.5T MRI System operated with the Medical Advances Quadrature Lower Extremity Coil addressed in this PMN, has the same intended use and technological characteristics as the same system operated without the Medical Advances Quadrature Lower Extremity Coil. The use of this coil does not affect the Philips Gyroscan ACS-NT 1.5T System safety parameter specifications.
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
#### Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 2 1999
Thomas E. Tynes Vice President, Operations Medical Advances, Inc. 10437 Innovation Drive Milwaukee, Wisconsin 53226 Re:
K991724 Model 473PH Series: Quadrature Lower Extremity Coil Dated: May 17, 1999 Received: May 20, 1999 Regulatory Class: II 21 CFR 892.1000/Procode: 90 MOS
Dear Mr. Tynes:
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). 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 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 Requlations, 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 requlatory 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 requlation 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".
Sincerely yours,
[signature]
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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Page of 1 I
长991724 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Model 473PH Series: Quadrature Lower Extremity Coil
Indications for Use:
Magnetic resonance imaging (MRI) of the knee, ankle, foot, and associated structures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David b. Seymon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
---
**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K991724](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K991724)
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