IMCO-STAT™ is a software device that receives digital images and data from existing imaging equipment using DICOM 3.0 communication protocols. Images and data are stored on the IMCO-STAT™ server in DICOM 3.0 Part 10 and JPEG format. IMCO-STAT™ is designed to send reports, images, audio and video data to other workstations, Personal Digital Assistants (PDA) or Tablet PCs in wired or wireless environments. This is accomplished using an executable client application on a receiving entity with the appropriate hardware. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Device Story
IMCO-STAT™ is a software-based image management system receiving DICOM 3.0 inputs from medical imaging equipment. It stores data in DICOM Part 10 and JPEG formats on a server. The system transmits reports, images, audio, and video to client workstations, PDAs, or Tablet PCs via wired or wireless networks. It provides tools for image viewing, including annotation, measurement, cine loops, comparison modes, and window/level control. Designed for use by healthcare professionals inside and outside radiology departments. The output allows clinicians to review patient studies remotely or at the point of care, facilitating clinical decision-making through access to diagnostic images on mobile or standard hardware. It benefits patients by enabling faster access to imaging data for clinical review.
Clinical Evidence
No clinical data. Bench testing only. Validation performed by programmers, non-programmers, quality control personnel, and potential customers to verify software functionality and hardware integration.
Indicated for clinical review of digital medical images and data received from imaging equipment via DICOM 3.0. Supports transmission to workstations, PDAs, and Tablet PCs. Contraindicated for primary interpretation of lossy compressed mammographic images or digitized film screen images; mammographic interpretation requires FDA-approved 5 Mpixel resolution monitors.
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).
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows a logo for IMCO Technologies. The logo features the letters "IMCO" in a bold, sans-serif font, with the letters arranged horizontally. The word "TECHNOLOGIES" is written in a smaller font below the letters "IMCO". The letters are in a dark color, and the background is white.
DEC 1 2 2006
The Image Management Company
510(k) Summary
In accordance with the provisions of the Safe Medical Device Act of 1990. IMCO Technologies is providing a summary of safety and effectiveness information regarding the IMCO-STAT™ software
- 1 1 Company Identification
IMCO Technologies N27W23957 Paul Road Pewaukee WI 53072 Contact. Mark Schwartz, President and CEO Telephone, 262-523-4445 Fax: 262-523-1141 Email: mschwartz@jmco-tech.com
- 1.2 Official Correspondent
Mark Schwartz. President and CEO IMCO Technologies N27W23927 Paul Rd Pewaukee WI 53072 Telephone: 262-523-4445 Fax: 262-523-1141 Email: mschwartz@imco-tech.com
- 1.3 Date of Submission
November 7, 2006
- 1 4 Device Name
Classification Name Common/Usual Name Proprietary Name:
System. Image Processing, Radiological Soft-copy reading system IMCO-STAT TH
- 1.5 Substantial Equivalence
The IMCO-STAT™ system has the same intended uses and technical characteristics as the Medical Insight EasyViz system (K051809) and Marotech, Inc. Marosis PACS System (K012844).
IMCO Technologies 510(k) Summary Page | 01 |
{1}------------------------------------------------
| Product Name | IMCO Stat | Medical<br>Insight<br>EasyViz | Marosis<br>PACS |
|-----------------------------------------------|-----------|-------------------------------|-----------------|
| Graphical UI | Yes | Yes | Yes |
| Windows O.S. - Client | Yes | Yes | Yes |
| Uses Standard Monitor | Yes | Yes | Yes |
| Scales Image to Display | Yes | Yes | Yes |
| Image Input | DICOM 3.0 | DICOM 3.0 | DICOM 3.0 |
| Images stored on remote Window server | Yes | Yes | Yes |
| Network Protocol | TCP-IP | TCP-IP | TCP-IP |
| Compression | JPEG 2K | Proprietary | JPEG 2K |
| Wireless Capability | Yes | Yes | No |
| Support Tablet PC, PDA, etc | Yes | Yes | No |
| Annotation | Yes | Yes | Yes |
| Image Measurement | Yes | Yes | Yes |
| Cine tool | Yes | Yes | Yes |
| Comparison Mode | Yes | Yes | Yes |
| Review Report from RIS | No | Yes | Yes |
| Designed for Use Inside and Outside Radiology | Yes | Yes | Yes |
| Flip / Rotate of Images | Yes | Yes | Yes |
| User Log In | Yes | Yes | Yes |
| Multiple Layout Options | Yes | Yes | Yes |
| WWL control & Pre-sets | Yes | Yes | Yes |
| Patient & Study Browser | Yes | Yes | Yes |
| Print to Paper Capability | No | Yes | Yes |
## 1.6
## Device Description and Intended Use
IMCO-STAT™ is a software device that receives digital images and data from existing imaging equipment using DICOM 3.0 communication protocols. Images and data are stored on the IMCO-STAT™ server in DICOM 3 0 Part 10 and JPEG format.
IMCO-STAT™ is designed to send reports, images, audio and video data to other workstations, Personal Digital Assistants (PDA) or Tablet PCs in wired or wireless environments. This is accomplished using an executable client application on a receiving entity with the appropriate hardware.
The images may be embedded for reference in a DICOM image comprised report data, for distribution across a network and storage in a Picture Archive Communication System (PACS) with the original exam series data. Wavelet files can also be created and stored utilizing the same process. The algorithms used to create JPEG and wavelet images follow known and accepted protocols.
{2}------------------------------------------------
IMCO-STAT™ uses standard off-the-shelf hardware and commercially available IMOO-07/11-1650 and operating systems. The software communicates using computer plationne and operthe network used to support the TCP/IP stack is superfluous to IMCO-STAT™
## General Safety and Effectiveness Concerns. 1 . ?
The device labeling contains instructions for use and indications for use. The The "device" laboling" components specified are off-the-shelf computer components
Validation and Effectiveness:
Testing of the software and related hardware has been performed by programmers, non-programmers, quality control individuals and potential customers
Lossy compressed mammographic images and digitized film screen images must Eosby comproboa nor primary image interpretations. Mammographic images may not be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Substantial Equivalence
As stated previously, IMCO-STAT™ is substantially equivalent to EasyViz software package and Marosis PACS.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Mark L. Schwartz President / CEO IMCO Technologies N27W23957 Paul Road #101 PEWAUKEE WI 53072
DEC 1 2 2006
Re: K063392
Trade/Device Name: IMCO-STATTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 7, 2006 Received: November 9, 2006
Dear Mr. Schwartz:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top. The letters "FDA" are in large, bold font in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial".
Protecting and Promoting Public Health
{4}------------------------------------------------
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.
This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/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
Page 2 -
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows a logo with the text "IMCO" in a stylized font. The top half of the letters "MC" are black, while the rest of the letters are in a lighter shade. Below the logo, the word "TECHNOLOGIES" is written in a simple, sans-serif font.
The Image Management Company
## INDICATIONS FOR USE
KOL 3392 510(k) Number (if known):
IMCO-STATTM Device Name:
IMCO Technologies Sponsor Name:
Indications for Use:
IMCO-STATTM is a software device that receives digital images and data from existing imaging equipment using DICOM 3.0 communication protocols. Images and data are stored on the IMCO-STATTM server in DICOM 3.0 Part 10 and JPEG format.
IMCO-STAT™ is designed to send reports. images, audio and video data to other workstations, Personal Digital Assistants (PDA) or Tablet PCs in wired or wireless environments. This is accomplished using an executable client application on a receiving entity with the appropriate hardware.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Prescription Use (21 CFR 801 Subpart D) And/Or
Over-The-Counter Use | | (21 CFR 807 Subpart C)
Do Not Write Below This Line - Continue on Another Page if Needed
Concurrence of CDRH, Office of Device Evaluation
David ln Ingram
(Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number
IMCO Technologies N27 W23957 Paul Road, Pewaukee, WI 53072 PH: 800/300-7734 262/523-4445 FX: 262/523-1141
www.imco-tech.com
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.
