K021262 · Usa Instruments, Inc. · MOS · May 21, 2002 · Radiology
Device Facts
Record ID
K021262
Device Name
MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL
Applicant
Usa Instruments, Inc.
Product Code
MOS · Radiology
Decision Date
May 21, 2002
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1000
Device Class
Class 2
Indications for Use
The Magnetom Symphony Quadrature Head Coil is a quadrature transmit receive coil used for obtaining diagnostic images of the head at the 1.5Tesla field strength in Magnetic Resonance Imaging. The indications for use are the same as for standard MR imaging. The Magnetom Symphony Head Coil is designed for use with the Siemens Magnetom Symphony 1.5Tesla MRI Scanner.
Device Story
The Magnetom Symphony Head Coil is a 16 z-element quadrature transmit/receive coil designed for 1.5T MRI scanners. It captures hydrogen nuclei signals to generate diagnostic images of the head, neck, and upper chest. The device features a rigid, split-top housing with a viewing window to accommodate various head sizes and improve patient comfort. It operates by receiving RF signals from the patient; active and passive switched diodes and RF fuses prevent resonance loops and RF burns. The coil is used in clinical imaging environments by trained MRI technicians and radiologists. Output images are interpreted by physicians to assist in clinical diagnosis. The device benefits patients by providing high-quality diagnostic imaging for soft tissue and vascular structures.
Clinical Evidence
Bench testing only. No clinical data provided. Safety and effectiveness were established through comparative analysis of technical specifications, including decoupling performance (≤ -55db), RF safety mechanisms (SAR algorithm, diode switching), and material composition.
Technological Characteristics
16 z-element quadrature transmit/receive coil. Materials: Polyurethane plastic, vinyl-coated foam. Decoupling: Active and passive switched diodes. RF safety: Pin diodes for channel isolation, fast-blowing RF fuses, non-conductive housing. Form factor: Rigid split-top design with viewing window. Connectivity: Dedicated interface for Siemens Magnetom Symphony 1.5T MRI scanner.
Indications for Use
Indicated for diagnostic MRI imaging of the brain, cervical spine, soft tissues, and vasculature of the head, neck, and upper chest. Used with 1.5T Siemens Magnetom Symphony scanners to produce images based on proton density, T1, and T2 relaxation times for physician interpretation. No specific age or gender contraindications stated beyond standard MRI safety protocols.
Regulatory Classification
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.
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## SUMMARY OF SAFETY AND EFFECTIVENESS
K021262
| 1-1 Device Name: | Magnetic Resonance Diagnostic Device |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1-2 Proprietary Name: | Magnetom Symphony Head Coil |
| 1-3 Classification: | Class II |
| 1-4 Establishment Registration | 1529041 |
| 1-5 Manufacture Facility Location | USA Instruments, 1515 Danner Drive<br>Aurora, Ohio 44202 USA<br>Telephone: 330-562-1000; Fax: 330-562-1422 |
| 1-6 Performance Standard: | No applicable performance standards have<br>been issued under Section 514 of the Food,<br>Drug and Cosmetic Act. |
| 1-7 Intended Use: | The Magnetom Symphony Quadrature Head<br>Coil is a quadrature transmit receive coil used<br>for obtaining diagnostic images of the head at<br>the 1.5Tesla field strength in Magnetic<br>Resonance Imaging. The indications for use<br>are the same as for standard MR imaging. The<br>Magnetom Symphony Head Coil is designed for<br>use with the Siemens Magnetom Symphony<br>1.5Tesla MRI Scanner. |
| 1-8 Device Description: | The Magnetom Symphony Head Coil is a 16 z-<br>element quadrature transmit receive coil. The<br>coil elements and associated circuitry are<br>enclosed to prevent any exposure to patient or<br>environment. The coil electronics are enclosed<br>in a rigid former. The former is a split top<br>design with latching device and a large open<br>viewing window on the top. The coil design<br>facilitates the scanning of patients with different<br>head sizes and maximizes patient comfort and<br>ease of use. |
Section 1, Page 1
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1-9 Safety and Effectiveness:
| Magnetom Symphony Head Coil | Comparison to Predicate or other 510(k)<br>cleared products |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Intended Use: Head Imaging<br>including diffusion weighted imaging,<br>angiography, functional MRI, CSI<br>imaging, and 3D TOF imaging. | -Similar to the Allegra 3.0Tesla Tx/Rx Head<br>Coil manufactured by USA Instruments, Inc.<br>(K002179) |
| Indications for Use: Identical to<br>routine MRI imaging | -Similar to the Vision 1.5Tesla Tx/Rx Head<br>Coil manufactured by Siemens Medical<br>Systems. (K932271) |
| Coil Enclosure Material:<br>Polyurethane Plastic, Vinyl coated<br>Foam | -Similar to the Allegra 3.0Tesla Tx/Rx Head<br>Coil manufactured by USA Instruments, Inc.<br>(K002179) |
| Coil Design: 16 z-element transmit<br>receive Quadrature design | -Similar to the Allegra 3.0Tesla Tx/Rx Head<br>Coil manufactured by USA Instruments, Inc.<br>(K002179) |
| Decoupling: Active and Passive<br>switched diodes; sensitivity when coil<br>is switched off is ≤ -55db. | -Similar to the Vision 1.5Tesla Tx/Rx Head<br>Coil manufactured by Siemens Medical<br>Systems. (K932271) |
| Prevention of RF Burns: The Coil's<br>transmit/receive switch uses pin<br>diodes to isolate the receive channel<br>from the transmit channel; coil<br>elements and circuitry are enclosed in<br>a non-conductive housing | -Similar to the Vision 1.5Tesla Tx/Rx Head<br>Coil manufactured by Siemens Medical<br>Systems. (K932271) |
| Radio Frequency Absorption:<br>Power deposition during imaging is<br>limited by SAR algorithm | -Similar to the Vision 1.5Tesla Tx/Rx Head<br>Coil manufactured by Siemens Medical<br>Systems. (K932271) |
| Formation of Resonance Loops:<br>Active diodes and fast blowing RF<br>fuses isolate the coil elements from<br>RF fields; length of cable and stiffness<br>does not permit looping. | -Similar to the Vision 1.5Tesla Tx/Rx Head<br>Coil manufactured by Siemens Medical<br>Systems. (K932271) |
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## DEPARTMENT OF HEALTH & HUMAN SERVICES
## Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
**MAY 21 2002**
Ms. Christie Shumaker Manager QA and Regulatory USA Instruments, Inc. 1515 Danner Drive AURORA OH 44202
Re: K021262
Trade/Device Name: Magnetom Symphony Quadrature Tx/Rx Head Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: April 17, 2002 Received: April 22, 2002
Dear Ms. Shumaker:
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 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.
.
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Page 2
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/dsma/dsmamain.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
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USA INSTRUMENTS, INC.
MAGNETOM SYMPHONY T/R HEAD COIL 510(K) APPLICATION
Page 1 of 1
510(k) Number (if known):_长02ノ262
Device Name: Magnetom Symphony Head Coil
Indications for Use: The Magnetom Symphony Head Coil is designed to manoutions retic Resonance Images of the brain, cervical spine, soft tissues and provide wagnetie head, neck and upper chest. The Magnetom Symphony Head Coil is designed for use with the Magnetom Symphony 1.5Tesla scanner manufactured by Siemens Medical Systems.
> Anatomic Regions: Soft tissues and vasculature of the head, neck and upper chest. Hydrogen Nuclei Excited:
The indications for use are the same as for standard imaging:
The 1.5Tesla MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, Intagoo that: (1) conceptrameters (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 _
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
David A. Larson
(Division Sign-Ofm-
Division of Reproductive, Abdominal,
and Radiological Devices:
510(k) Number K021262
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
