The Review Software products Echo-View 5.x, Easy-View 2.x, Omni-View 2.x, Cardio-View 1.x, LV Analysis 1.x, and Surgical View 1.x are intended to retrieve, analyze and store digital ultrasound images and Color Doppler images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. Echo-View 5.x, Easy-View 2.x, Omni-View 2.x, Cardio-View 1.x, LV Analysis 1.x and Surgical View 1.x can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology.
Device Story
Software suite for analysis, storage, retrieval, and reconstruction of digitized ultrasound B-mode and Color Doppler images. Inputs: digital 2D/3D image files from TomTec acquisition stations or 3D-capable ultrasound systems. Processing: 3D tomographic reconstruction and surface rendering of 3D/4D data sets; 2D/3D measurements. Output: reconstructed 3D volumes and processed images for clinical review. Used in clinical settings (cardiology, radiology, etc.) by healthcare professionals. Facilitates visualization and quantification of anatomical structures to support clinical decision-making and diagnosis.
Clinical Evidence
No clinical data. Bench testing only. Software testing and validation performed at module and system levels according to internal company protocols.
Technological Characteristics
Software-based digital ultrasound image analysis system. Operates on Microsoft Windows 2000/XP platforms. Features include 3D tomographic reconstruction, surface rendering, and 2D/3D measurement tools. Modular architecture with subsets of core Echo-View functionality. No specific hardware materials or energy sources defined as it is a software-only product.
Indications for Use
Indicated for use as a general purpose digital 3D ultrasound image processing tool for patients undergoing diagnostic imaging in cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics, and gynecology.
Regulatory Classification
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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KD22824
Image /page/0/Picture/1 description: The image shows the logo for TOMTEC Imaging Systems. The logo is in black and white, with the word "TOMTEC" in large, bold letters. Below the word "TOMTEC" are the words "IMAGING SYSTEMS" in smaller letters. The logo is simple and modern, and it is likely used to represent the company's brand.
July 318t , 2001
# Special 510(k) Summary
Echo-View 5.x Easy-View 2.x Omni-View 2.x Cardio-View 1.x LV Analysis 1.x Surgical View 1.x
OCT 1 7 2002
#### Name and Address
TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim
#### Contact Person
Florian Eisenberger Director, Requlatory Affairs & Quality Assurance ++49-89-32175-830 Phone ++49-89-32175-750 fax
### Common, Classification & Proprietary Names
Common Name: Classification Name: Proprietary Name(s): Digital Ultrasound Image Analysis System Ultrasonic Pulsed Echo Imaging System Echo-View 5.x Easy-View 2.x Omni-View 2.x Cardio-View 1.x LV Analysis 1.x Surgical View 1.x
#### Predicate Device
TomTec Echo-View K993398
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Image /page/1/Picture/0 description: The image shows the logo for Tomtec Imaging Systems. The logo is in black and white and features the word "Tomtec" in a bold, sans-serif font. Below the word "Tomtec" is the phrase "Imaging Systems" in a smaller, sans-serif font. The logo is simple and modern.
# Device Description
The Review Software products
- . Echo-View 5.x
- Easy-View 2.x ●
- Omni-View 2.x
- Cardio-View 1.x ●
- LV Analysis 1.x .
- Surgical View 1.x ●
are software modules for high performance computer systems based on Microsoft Windows 2000/XP™ operating system standards. These Review Software products are proprietary software for the analysis, storage, retrieval and reconstruction of digitized ultrasound B-mode images and Color Doppler images. The data can be acquired by a TomTec acquisition station or by a 3D capable ultrasound system. The result of acquired images allows a 3-dimensional volume to be reconstructed by Echo-View. The digital 3D / 4D data set can be used for 2D and 3D measurements.
# Intended Use
The Review Software products
- Echo-View 5.x .
- Easy-View 2.x .
- Omni-View 2.x .
- Cardio-View 1.x .
- LV Analysis 1.x .
- . Surgical View 1.x
are intended to retrieve, analyze and store digital ultrasound images and Color Doppler images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.
Echo-View 5.x , Easy-View 2.x. Omni-View 2.x, Cardio-View 1.x, LV Analysis 1.x and Surqical View 1.x can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics and aynecology.
# Technological Characteristics Comparison
Echo-View 5.x , Easy-View 2.x, Omni-View 2.x, Cardio-View 1.x, LV Analysis 1.x and Surgical View 1.x are modified version and follow-up products of the filed Echo-View / Easy-View system, which has been transferred to Windows 2000/XP ™ operating system standards. The graphic user interface has been improved for faster and easier application.
While Echo-View includes the full functionality the products Cardio-View, LV Analysis, Surgical View, Easy-View and Omni-View are subsets of the Echo-
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Image /page/2/Picture/0 description: The image shows the logo for Tomtec Imaging Systems. The word "Tomtec" is in large, bold, black letters. Below that, in smaller letters, are the words "Imaging Systems."
View Software where the functionality is limited for easier software handling with respect to the software application.
# Test Discussion
Testing was performed according to internal company procedures. Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release.
# Test Conclusions
Test results support the conclusion that actual device performance satisfies the design intent. Actual device performance as tested internally conforms to the system performance specifications.
July 31st , 2002
Florian Eisenberger
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Image /page/3/Picture/1 description: The image shows a circular logo with a stylized eagle in the center. The eagle is depicted with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the upper half of the circle, following its curvature. The logo appears to be a seal or emblem, possibly representing a government agency.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Florian Eisenberger Manager Regulatory Affairs TomTec Imaging System Edisonstrasse 6 D-85716 Unterschleissheim Germany
Re: K022824
Trade/Device Name: TomTec Echo-View 5.x, Fasy-View 2.x. Omni-View 2.x. Cardio-View 1.x. LV Analysis 1.x, and Surgical View 1.x Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 LLZ and IYO Dated: September 16, 2002 Received: September 24, 2002
Dear Mr. Eisenberger:
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 adultcration.
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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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. Snogdon
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: . TomTec Echo-View 5.x, Easy-View 2.x, Omni-View 2,x Cardio-View 1.x, LV Analysis 1.x, Surgical-View 1.x
### Indications For Use
The products:
- Echo-View 5.x ●
- Easy-View 2.x
- Omni View 2.x
- Cardio-View 1.x ●
- LV Analysis 1.x ●
- Surgical View 1.x ●
are intended to retrieve, analyze and store digital ultrasound images and Color Doppler images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.
Echo-View 5.x , Easy-View 2.x, Omni-View 2.x, Cardio-View 1.x, LV Analysis 1.x and Surgical View 1.x can import certain digital 2D or 3D image file formats for 3D tomographic reconstructions and surface rendering. It is intended as a general purpose digital 3D ultrasound image processing tool for cardiology, radiology, neurology, gastro-enterology, urology, surgery, obstetrics and gynecology.
(PLEASE DO NOT WRITE BELOW LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODF)
Trink M. Segmen
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022824
OR
Over-The-Counter Use
Prescription Use V (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.
