K980114 · GE Medical Systems · LNH · Mar 30, 1998 · Radiology
Device Facts
Record ID
K980114
Device Name
MAGNETIC RESONANCE DIAGNOSTIC SYSTEM
Applicant
GE Medical Systems
Product Code
LNH · Radiology
Decision Date
Mar 30, 1998
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1000
Device Class
Class 2
Indications for Use
The Signa CVMR system is a whole body scanner designed for shorter scan times. The Signa CVMR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa CVMR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Device Story
Signa CVMR is a modified whole-body magnetic resonance imaging (MRI) system. It utilizes a superconducting magnet to acquire 2D (single/multi-slice) and 3D volume images based on proton density, T1, T2, and flow. The system incorporates an upgraded Body/Gradient coil to provide expanded gradient capabilities, enabling shorter scan times compared to the predicate. Imaging options include cardiac/peripheral gating, flow compensation, and fat/water suppression to mitigate motion artifacts. Operated by trained professionals in clinical settings, the system produces images for interpretation by physicians to assist in clinical diagnosis. The device functions as a diagnostic imaging tool; it does not introduce new hazards or indications.
Clinical Evidence
Bench testing only. The device was evaluated against NEMA performance standards and IEC 601-1 and IEC 601-2-33 safety standards for magnetic resonance equipment. No clinical data provided.
Technological Characteristics
Superconducting magnet MRI system; utilizes Body/Gradient coil for expanded gradient capabilities. Supports pulse sequences including inversion recovery, spin echo, gradient echo, gradient recalled, and steady state free precession. Imaging features: cardiac/peripheral gating, flow compensation, fat/water suppression. Complies with NEMA performance standards and IEC 601-1/601-2-33 safety standards.
Indications for Use
Indicated for use as a diagnostic whole-body MR imaging device for patients requiring transverse, sagittal, coronal, and oblique internal structure imaging. No specific age or gender contraindications stated.
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.
Predicate Devices
Signa Horizon System
Submission Summary (Full Text)
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K98 0 11
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GE Medical Systems
P.O. Box 414, W-709 Milwaukee, WI 53201 USA
MAR 3 0 1998
## SUMMARY OF SAFETY AND EFFECTIVENESS
- This 510(k) summary of safety and effectiveness information is submitted in accordance o with the requirements of 21 CFR Part 807.87(h).
- 0 Identification of Submitter Larry A. Kroger, Ph.D., 414-544-3894, January 8, 1998
- o Identification of the Product Signa CVMR Magnetic Resonance System
Manufactured by:
GE Medical Systems 3200 N. Grandview Blvd. Waukesha, WI 53188
#### o Marketed Devices
The Signa CVMR System is substantially equivalent to the currently marketed Signa Horizon System with the only difference being a different Body/Gradient coil.
#### o Device Description
The Signa CVMR System is a modification to the Signa Horizon MR Systems which utilize a superconducting magnet to acquire 2D single-slice and multi-slice, and 3D volume images. In addition to the wide variety of pulse sequences provided to the Signa Horizon operator, such as inversion recovery, spin echo, gradient echo, gradient recalled, and steady state, and free precession acquisitions, the Signa CVMR operator has the ability for shorter scan times due to expanded gradient capabilities. Imaging options such as cardiac gating, peripheral gating, flow compensation and fat/water suppression are provided to suppress artifacts due to physiological motion and improve image quality.
#### o Indications for Use
The Signa CVMR system is a whole body scanner designed for shorter scan times. The Signa CVMR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa CVMR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spinspin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
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GE Medical Systems
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P.O. Box 414, W-709 Milwaukee, WI 53201 USA
# SUMMARY OF SAFETY AND EFFECTIVENESS
#### o Comparison with Predicate
The Signa CVMR System is comparable to the Signa Horizon Systems with the main difference being with the Body/Gradient coil which allows for expanded gradient capabilities, enabling shorter scan times.
#### o Summary of Studies
The Signa CVMR System was evaluated to the appropriate NEMA performance standards as well as the IEC 601-1 International medical equipment safety standard and IEC 601-2-33 Particular requirements for the safety of magnetic resonance equipment for medical diagnosis. The Signa CVMR System is comparable to the Signa Horizon MR Systems.
### Conclusions
0
It is the opinion of GE that the Signa CVMR System is substantially equivalent to the Signa Horizon MR Systems. The Signa CVMR Magnetic Resonance System does not include any new indications for use, nor does use of this device result in any new potential hazards.
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# MAR 3 0 1998
Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager GE Medical Systems, Inc. P.O. Box 414, W-709 Milwaukee, WI 53201
Re:
K980114 Signa CVMR Magnetic Resonance System Dated: January 12, 1998 Received: January 13, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Kroger:
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 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). 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (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 regulatory action. In addition, FDA may publish further announcements coucerning 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 vito 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 regulation 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/cdrb/dsmaldsmam.html".
Sincerely yours,
Kiliai Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_ K98 0114
Device Name: Signa CVMR System
Indications For Use:
The Signa CVMR system is a whole body scanner designed for shorter scan times. The Signa CVMR system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the Signa CVMR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Seysom
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devic 510(k) Number
OR
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
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.
