Eastman Kodak DirectView PACS/Image Management System(DV PACS) intended use is to provide completely scaleable image/data management solutions for hospital and related institutions/sites including, at a minimum, local to wide area primary diagnostic workstations to enterprise storage centers. DV PACS also provides services that will allow remote sites to have access to diagnostic image/patient data through industry standard interfaces, including web browsers supported by Eastman Kodak and other's predicate devices. DV PACS is designed using an open architecture that allows various proprietary and off the shelf (OTF) software integrated with OTF hardware components to be configured to meet the user's specific needs. Using DICOM and other industry standards, DirectView PACS archives/ distributes/retrieves and displays images and data from all hospital modalities including but not limited to, CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), mammography, cardio systems, digitized X-ray films, digital angiography, and fluoroscopy as well as all hospital/radiology information systems.
Device Story
Kodak DirectView PACS is a scalable image and data management system for hospitals and clinical institutions. It ingests medical images and patient data from diverse modalities—including CT, MRI, Ultrasound, CR, DR, Nuclear Medicine, mammography, and digital angiography—as well as hospital and radiology information systems. The system utilizes an open architecture, integrating proprietary and off-the-shelf software and hardware to archive, distribute, retrieve, and display diagnostic data. It supports local and wide-area networks, enabling remote access via industry-standard interfaces and web browsers. Operated by radiologists and clinicians, the system provides diagnostic-quality visualization at primary workstations. By centralizing image management and facilitating efficient data retrieval, the device supports clinical decision-making and workflow optimization across the enterprise.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on feature comparison and functional demonstration.
Technological Characteristics
Open architecture system integrating off-the-shelf hardware and software. Utilizes DICOM and industry-standard interfaces for connectivity. Supports local and wide-area network configurations. Designed for enterprise-level image archiving, distribution, and diagnostic display.
Indications for Use
Indicated for use in hospital and clinical settings to archive, distribute, retrieve, and display medical images and data from various modalities (CT, MRI, US, CR, DR, NM, mammography, cardio, digital angiography, fluoroscopy) and information systems. For use by healthcare professionals.
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).
Predicate Devices
AccuRad
Archive Manager
Submission Summary (Full Text)
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MAY 2 9 2003
#### 510(k) Summary 6.1
### 1. Company Identification
Eastman Kodak Company 343 State Street Rochester, NY 14650
#### 2. Contact Person
Linda J. Moore, Dir.of Regulatory Affairs, HCIS Products Eastman Kodak Health Imaging 47315 Mission Falls Ct. Fremont, CA 94539 510-770-5456 Fax. 510-770-5544 Linda.j.moore@kodak.com
#### 3. 510(k) Summary Preparation Date
March 7, 2003
#### 4. Device Name
Kodak DirectView PACS/Image Management Systems
#### 5. Device Classification
Class II
#### 6. Intended Use/Device Description
Eastman Kodak DirectView PACS/Image Management System(DV PACS) intended use is to provide completely scaleable image/data management solutions for hospital and related institutions/sites including, at a minimum, local to wide area primary diagnostic workstations to enterprise storage centers. DV PACS also provides services that will allow remote sites to have access to diagnostic image/patient data through industry standard interfaces, including web browsers supported by Eastman Kodak and other's predicate devices. DV PACS is designed using an open architecture that allows various proprietary and off the shelf (OTF) software integrated with OTF hardware components to be configured to meet the user's specific needs. Using DICOM and other industry standards, DirectView PACS archives/ distributes/retrieves and displays images and data from all hospital modalities including but not limited to, CT, MRI, Ultrasound
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(US), CR, DR, Nuclear Medicine (NM), mammography, cardio systems, digitized X-ray films, digital angiography, and fluoroscopy as well as all hospital/radiology information systems.
## 7. Substantial Equivalence Summary
The DirectView PACS/Image Management System is substantially equivalent in design and intended use to diagnostic radiological workstations, PACS and image management systems as substantiated in the feature comparison. The comparison listed in Section 3.3 clearly demonstrates that DirectView PACS/Image Management System is substantially equivalent in all areas such as functionality, user/software features, hardware components and connectivity. Although, the comparison only lists DirectView PACS equivalence to its predecessors. AccuRad and Archive Manager, the stated indications for use, listed on the comparison, does show substantial equivalence to other manufacturer's industry standard PACS/image management systems. Therefore, DirectView PACS raises no new issues of safety or effectiveness from its predicate devices.
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Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, stacked on top of each other. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 2003
Ms. Linda J. Moore Director, Regulatory Affairs, HCIS Products Eastman Kodak Company 47315 Mission Falls Ct. FREMONT CA 94539
Re: K030781
Trade/Device Name: Kodak DirectView PACS/Image Management System Regulation Number: 21 CFR \$892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: March 7, 2003 Received: March 11, 2003
Dear Ms. Moore:
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 (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 Brogdon
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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# 6.2 FDA Indications for Use
510K # K03078|
Device Name: Kodak DirectView PACS/Image Management System
The Kodak DirectView PACS is an image management system whose Indications for Use: intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive/ distribute/ retrieve and display images and data from all hospital modalities and information systems.
| | Concurrence of CDRH, Office of Device Evaluation |
|--|--------------------------------------------------|
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Prescription Use (Per 21 CFR 801.109)
OR
Over - The - Counter _________________________________________________________________________________________________________________________________________________________
David R. Bergman
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.
