K050307 · Hitachi Medical Systems America, Inc. · MOS · Feb 28, 2005 · Radiology
Device Facts
Record ID
K050307
Device Name
AIRIS ELITE RAPID BODY COIL
Applicant
Hitachi Medical Systems America, Inc.
Product Code
MOS · Radiology
Decision Date
Feb 28, 2005
Decision
SESE
Submission Type
Abbreviated
Regulation
21 CFR 892.1000
Device Class
Class 2
Indications for Use
The MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The body coil is a receive-only device that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the body. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination. The indications for use are as follows: Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.
Device Story
AIRIS Elite Rapid Body Coil is a receive-only RF phased array coil for open MRI systems; used for abdominal imaging. Device consists of rigid upper section and base positioned around patient abdomen; contains four coil elements (two-turn solenoid, anterior saddle, posterior saddle, anti-turn loop) in plastic housing. Coil detects RF emissions from hydrogen nuclei relaxation; signals processed by MRI system to reconstruct 3D images. Operated by MRI technicians/radiologists in clinical settings. Output images interpreted by physicians for diagnostic purposes; aids in visualization of internal structures without ionizing radiation.
Clinical Evidence
No clinical data provided; substantial equivalence based on technological characteristics and bench testing.
Technological Characteristics
Receive-only RF phased array coil; four-channel design; rigid plastic housing; electrical pin connection; components include two-turn solenoid, anterior saddle, posterior saddle, and anti-turn loop. Operates within open MRI system environment.
Indications for Use
Indicated for MRI and MRA of musculoskeletal, soft tissue, and vascular structures in the chest to pelvic region.
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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K050307
# Section 2
# 510(k) Summary of Safety and Effectiveness
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### Submitter Information
| Submitter: | Hitachi Medical Systems America, Inc.<br>1959 Summit Commerce Park<br>Twinsburg, Ohio 44080-2371<br>ph: (330) 425-1313<br>fax: (330) 425-1410 |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Douglas J. Thistlethwaite |
| Date: | February 4, 2005 |
### Device Name
| Classification Name: | Coil, magnetic resonance, specialty |
|-------------------------|-------------------------------------|
| Classification Number: | 90MOS |
| Trade/Proprietary Name: | AIRIS Elite Rapid Body Coil |
| Predicate Device(s): | AIRIS Elite (K032232) |
## Device Intended Use
The MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The body coil is a receive-only device that detects the MR signal used to produce transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the body. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.
The indications for use are as follows:
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the musculoskeletal structures, soft tissue and vascular structures within the anatomic regions from the chest to the pelvic region.
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### Device Description
#### Function
The AIRIS Elite Body Coil (hereby referred to as body coil) is a receive only RF phased array coil, used for obtaining diagnostic images of the abdominal region, in an open Magnetic Resonance Imaging (MRI) system.
#### Scientific Concepts
Magnetic Resonance Imaging (MRI) is based on the fact that certain atomic nuclei have Magnetic properties that cause them to act as small spinning bar magnets. The most ubiquitous of these nuclei is hydrogen, which makes it the primary nuclei currently used in maquetic resonance imaging. When placed in a static magnetic field, these nuclei assume a net orientation or alignment with the magnetic field, referred to as a net magnetization vector. The introduction of a short burst of radiofrequency (RF) excitation of a wavelength specific to the magnetic field strength and to the atomic nuclei under consideration can specific to the magnetization vector. When the RF excitation is removed, the protons relax and return to their original vector. The rate of relaxation is exponential and the prototte rear. Caracter of the proton and its adjacent molecular environment. This revarres with arocess is characterized by two exponential relaxation times, called T1 and T2.
A RF emission or echo that can be measured accompanies these relaxation events. The receive coil detects these emissions which are used to develop a representation of the relaxation events in a three dimensional matrix. Spatial localization is encoded into the echnes by varying the RF excitation, applying appropriate magnetic field gradients in the x, y, and z directions, and changing the direction and strength of these gradients. Images depicting the spatial distribution of the NMR characteristics can be reconstructed by using image processing techniques similar to those used in computed tomography.
#### Physical and Performance Characteristics
The body coil consists two mechanical sections: a rigid removable upper section and a base, which is positioned above and below the patient abdomen respectively. The upper section can be connected to the base by the electrical pins. There is a latch on the upper section. The coil consists of four coil elements: a two-turn solenoid, an anterior saddle, a posterior saddle and an anti-turn loop. All the elements are enclosed in a rigid plastic housing. The signal output of each element is independently processed by the system to enhance performance.
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## Device Technological Characteristics
The technological characteristics of this device are similar to the predicate device. The device has four channels vs. two in the predicate device. Each channel output is independently processed.
### Conclusions
It is the opinion of Hitachi Medical Systems Amcrica that the AIRIS Elite RAPID Body Coil is substantially equivalent to the body coil cleared with the AIRIS Elite MRI System. The technological characteristics and intended use are identical to the Predicate Device.
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Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
FEB 2 8 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Douglas Thistlewaite Manager of Regulatory Affairs Hitachi Medical Systems America 1959 Summit Commerce Park TWINSBURG OH 44087-2371
Re: K050307
Trade/Device Name: AIRIS Elite Rapid Body Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: February 4, 2005 Received: February 8, 2005
Dear Mr. Thistlewaite:
We have reviewed your Section 510(k) premarket notification of intent to maket the device referenced in We have reviewed your Section 510(K) premants interests (for the indications for use stated in
above and have determined the device is substantially equivalse commerce prior above and have determined the devices marketed in interstate commerce prior to the enclosure) to legally marketed predical Device Amendments, or to devices that have been
May 28, 1976, the enactment date of the Medical Execut Development Casemane Ast (A May 28, 1976, the enactment date of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the provinsions of the A.). You may, therefore, market the do not require approval of a prematics approval approval controls provisions of the Act
device, subject to the general controls provisions of the Act. The Act device, subject to the general controls of the real "The game"
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 (Prematket If your device is classified (see above) incols. Existing major regulations affecting your Approval), it may be subject to such additional controls. "Little 21, Parts 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Pa device can be found in the Code of I concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised mat I DA S Issualice of a substance of the Act or any of the Act or any
FDA has made a determination that your device complies with semply with all FDA has made a determination mar your device comples. You must complex You must comply with all the Federal statutes and regulations administered by their reson and listing (21 CFR Part 807); labeling Act 's requirements, including, out not minited to registration as a to the internations of the visions (2) CFR Part 801); good filandiaciumig practice realertedic product radiation control provisions
regulation (21 CFR Part 820); and if applicable, the electronic product radia (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k)
10 legal This letter will allow you to begin harketing your avression of your device to a legally premarket notification. The FDA Inding of substantial equice 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 device on our labering regardants ( the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "visorianting of tresponsibilities under the Act from the 807.97). You may obtain other gelleral information on your respections
Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) Division of Binan Mas-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Hogdon
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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _AIRIS Elite Rapid Body Coil
Indications for Use:
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of the Magnetic resonance imaging (MRT) and magnetic resolulies within the anatomic regions from the chest to the pelvic region.
Over-the-Counter Use X AND/OR Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Legare
KD50307
Page 1 of 1
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.
