← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K063342 # MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS (K063342) _Medrad, Inc. · MOS · Nov 30, 2006 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K063342 ## Device Facts - **Applicant:** Medrad, Inc. - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Nov 30, 2006 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use The eCoil Imaging System for Philips MR scanners is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging, including spectroscopy, of the human colon, cervix or prostate and surrounding pelvic tissue. The purpose of the interface device for the eCoil Imaging System is to provide interface and support functions to allow the use of MEDRAD disposable endorectal coils with Philips MRI scanner systems. Only trained healthcare professionals are intended to operate this device. ## Device Story The MEDRAD eCoil Imaging System is a receive-only endorectal coil interface designed for use with Philips 1.5T and 3.0T MRI scanners. It functions as an accessory to enable the use of MEDRAD disposable endorectal coils. The system captures RF signals from pelvic tissues, which are then pre-amplified by the interface device before being transmitted to the MRI scanner for image reconstruction. The device is used in a clinical radiology setting by trained healthcare professionals. By providing high-resolution imaging and spectroscopy of the colon, cervix, and prostate, the system assists clinicians in visualizing pelvic anatomy, thereby supporting diagnostic decision-making. ## Clinical Evidence Bench testing only. ## Technological Characteristics Receive-only surface coil; interface device provides RF signal pre-amplification; active and passive decoupling; fixed tuning set in production; compatible with 1.5T and 3.0T Philips MRI scanners; uses MEDRAD disposable endorectal coils. ## 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. ## Predicate Devices - MEDRAD, INC. 3.0T Prostate Imaging System ([K051349](/device/K051349.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K063342 ## 510(k) Summary NOV 3 U 2006 | OFFICIAL CONTACT: | Lisa A. Ewing
Senior Regulatory Affairs Specialist
MEDRAD, INC.
One Medrad Drive
Indianola, PA 15051
(412) 767-2400 Ext. 3780 | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | CLASSIFICATION NAME: | Magnetic Resonance Diagnostic Device
(21 CFR 892.1000, Product Code MOS) | | COMMON NAME(S): | Magnetic Resonance Diagnostic Accessory | | PROPRIETARY NAME: | MEDRAD eCoil Imaging System for Philips | | PREDICATE DEVICES: | MEDRAD, INC. 3.0T Prostate Imaging System
(K051349) | | INTENDED USE: | The eCoil Imaging System for Philips MR
scanners is a receive-only coil intended for use as
a Magnetic Resonance Diagnostic Device
(MRDD) for high-resolution magnetic resonance
imaging, including spectroscopy, of the human
colon, cervix or prostate and surrounding pelvic
tissue. The purpose of the interface device for the
eCoil Imaging System is to provide interface and
support functions to allow the use of MEDRAD | support functions to allow the use of MEDRAD disposable endorectal coils with Philips MRI scanner systems. Only trained healthcare professionals are intended to operate this device. DEVICE DESCRIPTION AND COMPARISON TO UNMODIFIED PREDICATE: The MEDRAD eCoil Imaging System maintains a similar intended use, similar operational parameters, similar labeling and is used in a manner similar to the predicate device. The following comparison table identifies the similarities and differences between the proposed device and the predicate device. {1}------------------------------------------------ TABLE 1 Comparison of Features and Principles of Operation in MEDRAD 3.0T Prostate Imaging System Interface Device for Siemens (Predicate) and MEDRAD 3.01) Imaging System Interface Device for Siemens (Predicate) and MEDRAD eCoil Imaging System Interface Device for Philips (Proposed) | Feature | (Predicate)
MEDRAD 3.0T Prostate Imaging System Interface Device | (Proposed)
MEDRAD eCoil Imaging System Interface Device | |--------------------------------|---------------------------------------------------------------------|------------------------------------------------------------| | Coil Type | Receive-only surface coil | Receive-only surface coil | | Scanner Interface | 3.0T Siemens Trio scanners | 1.5T and 3.0T Philips scanners | | Coil Interfaces | MEDRAD 3.0T Endorectal Coils | MEDRAD 1.5T and 3.0T Endorectal Coils | | Decoupling | Active and passive | Active and passive | | RF Signal
Pre-Amplification | Performed by the interface device | Performed by the interface device | | Tuning | Fixed tuning set in production. | Fixed tuning set in production. | {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of a human figure. The figure is composed of three curved lines that represent the head, body, and legs. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 Ms. Lisa A. Ewing Senior Regulatory Affairs Specialist Medrad, Inc. One Medrad Drive INDIANOLA PA 15051-0780 NOV 3 0 2006 Re: K063342 Trade/Device Name: MEDRAD eCoil Imaging for Philips Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: November 3, 2006 Received: November 6, 2006 Dear Ms. Ewing: 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/10 description: The image shows a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906-1906" are printed. Below the letters, the word "Centennial" is printed in a cursive font. There are three stars below the word "Centennial". The logo is surrounded by a dotted border. Protecting and Promoting Public Health {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 C. Hogdon Nancy C. B rogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use K063342 510(k) Number: Device Name: MEDRAD eCoil Imaging System for Philips ## Indications for Use: The eCoil Imaging System for Philips MRI scanners is a receive-only coil intended for use as a Magnetic Resonance Diagnostic Device (MRDD) for high-resolution magnetic resonance imaging, including spectroscopy, of the human colon, cervix or prostate and surrounding pelvic tissue. The purpose of the interface device for the eCoil Imaging System is to provide interface and support functions to allow the use of MEDRAD disposable endorectal coils with Philips MRI scanner systems. trained healthcare professionals are intended to operate this device. Only Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | | signature | |---------------------------------------------------------------|--------------------------------------------| | (Division Sign-Off) | | | Division of Reproductive, Abdominal, and Radiological Devices | | | 510(k) Number | K063342 | - 6 - PPage 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K063342](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K063342) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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