CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT
K973799 · Siemens Medical Solutions USA, Inc. · LNH · Jan 2, 1998 · Radiology
Device Facts
Record ID
K973799
Device Name
CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT
Applicant
Siemens Medical Solutions USA, Inc.
Product Code
LNH · Radiology
Decision Date
Jan 2, 1998
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1000
Device Class
Class 2
Indications for Use
Siemens Cardiac Tagging pulse sequences for the Magnetom Vision and Impact systems allow for the non-invasive evaluation of cardiac wall motion and blood flow. Cardiac Tagging is intended as an add-on to routine MR imaging examinations of the heart and great vessels. Tagging may provide additional diagnostic information, which in the hands of a qualified physician, can be useful in the diagnosis of disease.
Device Story
Cardiac Tagging is a software-based pulse sequence add-on for Siemens Magnetom Vision and Impact MRI systems. It applies equally spaced saturation bands to generate a grid pattern on cardiac images. Used by physicians during routine MR cardiac examinations, the grid allows visual assessment of myocardial wall motion and blood flow. Absence of grid deformation indicates dysfunctional myocardium; grid patterns also assist in distinguishing fixed thrombus from slow-flowing blood. The device does not alter the underlying MRI hardware (magnet, RF, gradient systems). It provides diagnostic information to assist clinicians in evaluating cardiac disease states.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing and comparison of safety/performance parameters (static field strength, RF exposure, spatial resolution, slice thickness, geometric distortion, SNR, and image uniformity) against the predicate device.
Technological Characteristics
Software-based pulse sequences for MRI. Operates on existing Magnetom Vision and Impact hardware (magnet, RF, gradient systems). No changes to hardware or physical materials. Connectivity is integrated into the existing MRI system architecture. No specific software algorithm class or architecture stated.
Indications for Use
Indicated for non-invasive evaluation of cardiac wall motion and blood flow in patients undergoing routine MR imaging of the heart and great vessels. Used to identify dysfunctional myocardium via tag deformation analysis and to differentiate between fixed thrombus and slowly flowing blood.
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
Siemens Magnetom Cardiac Cine Techniques (K900889)
Submission Summary (Full Text)
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K97399
## 510 (k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. JAN - 2 1998 General Information. I.
- Establishment: Siemens Medical Systems, Inc. · Address: 186 Wood Avenue South Iselin, N.J. 08830 · Registration Number: 2240869 Kathleen M. Rutherford • Contact Person: Manager, Regulatory Submissions (908) 321-4779 October 3, 1997 · Date of Summary Preparation: Device Name: Cardiac Tagging Techniques/ · Trade Name: MAGNETOM Vision, Impact Magnetic Resonance Diagnostic · Classification Name: Device, CFR § 892.1000 Class II · Classification: None established under Section · Performance Standards: 514 of the Food, Drug, and Cosmetic Act.
# II. Safety and Effectiveness Information Supporting the Substantial Equivalence Determination.
## Device Description:
The Magnetom Cardiac Tagging Techniques consist of software and sequences designed to apply a series of equally spaced saturation bands to generate a grid on a cardiac image, for use in cardiac evaluation.
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#### Intended Use
Siemens Cardiac Tagging pulse sequences for the Magnetom Vision and Impact systems allow for the non-invasive evaluation of cardiac wall motion and blood flow.
### Technological Characteristics
The magnet, RF system, and gradient system of the Magnetom Vision and Impact configured with the Cardiac Tagging option are unchanged from that of the standard Magnetom Vision and Impact systems. Introduction of Cardiac Tagging will not affect the technological characteristics of the system, which allows presentation of images and other parameters based upon the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance.
## General Safety and Effectiveness Concerns:
Operation of the MAGNETOM Vision and Impact systems with the new Cardiac Tagging feature is substantially equivalent to standard operation of the MAGNETOM Vision and Impact system. The following safety parameter action levels:
- static field strength, ।
- RF exposure, r
and performance levels:
- high contrast spatial resolution, -
- slice thickness, -
- geometric distortion,
- -SNR, and
- image uniformity
specified by the FDA guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification.
## Substantial Equivalence:
Siemens believes that, within the meaning of the Safe Medical Device Act of 1990, MR Cardiac Tagging Techniques are substantially equivalent to Siemens Magnetom Cardiac Cine Techniques which were originally described in premarket notification K900889 which received FDA clearance on 03/23/90.
Kathleen Rutherford
Signature
10/3/97
Date
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three curved lines, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged in a circular fashion around the left side of the logo, with "SERVICES - USA" completing the circle at the bottom.
JAN - 2 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
Re: K973799
Cardiac Tagging Techniques for Magnetom Vision and Impact (MR accessory) Dated: October 3, 1997 Received: October 6, 1997 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Ms. Rutherford:
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 interestore) 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) 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 concerning 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 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 vitro 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/cdrh/dsmamain.html".
Sincerely yours,
h.J.Liau Yin
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) K17 3799 -----
Device Name: Cardiac Tagging
Indications for Use:
Siemens developed Cardiac Tagging pulse sequences for the Magnetom Vision and Impact Systems to allow for the non-invasive evaluation of cardiac wall motion and blood flow. Absence of tag deformation throughout the cardiac cycle is an indicator of dysfunctional myocardium which accompanies a variety of disease states. In addition, Cardiac Tagging may assist in differentiating between fixed thrombus and slowly flowing blood.
Cardiac Tagging is intended as an add-on to routine MR imaging examinations of the heart and great vessels. Tagging may provide additional diagnostic information, which in the hands of a qualified physician, can be useful in the diagnosis of disease.
(please do not write below this line- continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use_
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Kilian Yi
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number_
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.
