← Product Code [MOS](/productcode/MOS) · K020993 # ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB) (K020993) _Magna-Lab, Inc. · MOS · May 21, 2002 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K020993 ## Device Facts - **Applicant:** Magna-Lab, Inc. - **Product Code:** [MOS](/productcode/MOS.md) - **Decision Date:** May 21, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use The intended use of the Illuminator™ Automatic Tune Interface Box and Interface Cable is for high resolution Magnetic Resonance Imaging (MRI). It is used in conjunction with the Magna-Lab TE Probe and Surface Coil. ## Device Story The Illuminator™ Automatic Tune Interface Box (ATIB) serves as an interface between Magna-Lab Transesophageal (TE) Probes or Surface Coils and General Electric 1.5T Signa® MRI systems. The device automatically tunes the probe and matches electrical impedance to the MRI system, replacing manual tuning processes. It is intended for use in clinical MRI rooms by trained personnel. By automating the impedance matching, the device simplifies the setup process for the clinician, ensuring optimal signal quality for high-resolution imaging. The output is processed MRI data used by the clinician for diagnostic decision-making. ## Clinical Evidence Bench testing only. Performance testing included imaging performance comparisons between manual and automatic tune units, signal-to-noise ratio comparisons, and temperature measurements. ## Technological Characteristics Interface box and cable bundle with 30-pin connector. Functions as an impedance matching and tuning interface for MRI probes. Operates with GE 1.5T Signa® MRI systems. No changes to materials or fundamental design compared to manual predecessors. ## 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 - Transesophageal Probe ([K010513](/device/K010513.md)) - Surface Coil ([K010802](/device/K010802.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}------------------------------------------------ MAY 21 2002 Ko 20993 Premarket Notification - Illuminator™ Automatic Tune Interface Box Page 1 of 2 # 510(k) Summary of Safety and Effectiveness #### 1. Sponsor Name Magna-Lab, Inc. Six Kimball Lane, Suite 210 Lynnfield, MA 01940 Telephone: 781-246-4774 Contact Individual: John Geisel - 2. Device Name Illuminator™ Automatic Tune Box and Interface Cable (ATIB) ### Identification of Predicate or Legally Marketed Device 3. The Automatic Tune Interface Box (ATIB) is substantially equivalent to the manual tune interface unit cleared under K010513 for the Transesophageal Probe and K010802 for the Surface Coil. - Device Description 4. The Illuminator™ Automatic Tuning Interface Box (ATIB) provides an interface for the Illuminator™ Transesophageal Probe, the Illuminator ™ Surface Coil and the General Electric 1.5 T Signa® Magnetic Resonance Imaging (MRI) Systems. The device automatically tunes the Transesophageal (TE) Probe and matches the impedance of the probe to the interface of the MRI system. The Auto Tune Interface Box will be used in clinical MRI rooms. The interface box interfaces with the GE MRI machine through a cable bundle with a 30 pin connector box attached. - Intended Use 5. The intended use of the Illuminator™ Automatic Tune Interface Box and Interface Cable is for high resolution Magnetic Resonance Imaging (MRI). It is used in conjunction with the Magna-Lab TE Probe and Surface Coil. - Comparison of Technological Characteristics 6. The manual tune box is replaced by the auto tune box and cable, and the design and materials have not changed in any substantial way. Confidential {1}------------------------------------------------ Kozorq93 Razeloff Integrating the ATIB into the Illuminator™ Transesophageal Probe system does not alter or change its intended use. It is substantially equivalent to its predecessor, Transesophageal Probe (with manual tune box), the only difference being that the auto tune box automatically matches and simplifies the electrical impedance tuning process. - 7. Performance Testing Magna-Lab has performed testing and/or analysis of the Interface Box. This testing includes the following: - Imaging performance comparisons between the manual tune and . auto tune interface units. - Signal to Noise Comparisons ● - Temperature Measurements ● {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in bold font. The text is left-aligned. ood and Drug Administ 0 Corporate Boulevard Rockville MD 20850 Mr. John R. Geisel Chief Executive Officer Magna-Lab, Inc. Six Kimball Lane, Suite 210 LYNNFIELD MA 01940 Re: K020993 Trade/Device Name: Illuminator™ Automatic Tune Box and Interface Cable (ATIB) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: March 22, 2002 Received: March 27, 2002 Dear Mr. Geisel: 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. Iisting 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 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. 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. Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three birds in flight, arranged in a diagonal line. {3}------------------------------------------------ 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsmaldsmamain.html. Sincerely yours, Nancy C. Snogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure ## Page 2 。 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Magna-Lab Inc. The logo consists of a 3x3 grid of squares on the left, followed by the text "MAGNA-LAB INC." in a blocky, sans-serif font. The text is aligned to the right of the grid of squares. 510(k) Number (if known): Device Name: Illuminator™ Automatic Tune Box and Interface Cable (ATIB) Indications For Use: The intended use of the Illuminator™ Automatic Tune Interface Box and Interface Cable is for high resolution Magnetic Resonance Imaging (MRI). It is used in conjunction with the Magna-Lab TE Probe and Surface Coil. (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) Over-The-Counter Use David A. Nyman (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _ OR Confidential --- **Source:** [https://fda-staging.innolitics.com/device/K020993](https://fda-staging.innolitics.com/device/K020993) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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