KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT
K961739 · Kodak Health Imaging Systems, Inc. · LLZ · Nov 14, 1996 · Radiology
Device Facts
Record ID
K961739
Device Name
KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT
Applicant
Kodak Health Imaging Systems, Inc.
Product Code
LLZ · Radiology
Decision Date
Nov 14, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Indications for Use
The KODAK Ektascan Imagelink System (KEIS) is a DICOM conferment product designed for use within a Picture Archiving and Communication System (PACS). The KODAK Ektascan Imagelink System is composed of two major components, the KODAK Digital Science Medical Modality Acquisition Unit and the KODAK Digital Science Medical Printer Interface Unit. These systems can exit together or independently on a network.
Device Story
System functions as PACS component for diagnostic image management; acquires, prints, reviews, archives, and communicates medical images. Inputs include video signals (RS-170/CCIR, RGB) from modalities like C-Arm, DSA, Nuclear Medicine, and Ultrasound. Acquisition unit captures images in 1/30 second; stores on 2.5" hard drives. Printer Interface Unit supports DICOM v3.0/ACR-NEMA formats. Used in clinical environments by healthcare professionals to replace film cassettes and darkroom processing. Output provided as soft or hard copy for clinician review; facilitates diagnostic decision-making by streamlining image workflow and eliminating manual film handling.
Clinical Evidence
Bench testing only. No clinical data provided. Equivalence established through comparison of technical specifications, performance characteristics, and intended use.
Technological Characteristics
System components: Digital Science Medical Modality Acquisition Unit and Printer Interface Unit. Connectivity: Ethernet, DICOM v3.0/ACR-NEMA. Inputs: Monochrome RS-170/CCIR, RGB video. Storage: 2.5" hard drives (30, 60, 80, 105 Mbytes). Outputs: SCSI, Video, RS-485, RS-422, RS-232. Power: 90-132vac/47-63Hz or 180-264vac/47-63Hz. Environmental: 4-45 degrees C, 15-90% RH non-condensing.
Indications for Use
Indicated for use within a Picture Archiving and Communication System (PACS) for the management of diagnostic image information, including image acquisition, printing, review, archive/retrieval, and communications from modalities such as C-Arm, Digital Subtraction Angiography, Nuclear Medicine, Ultrasound, and other video modalities.
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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NOV-06-1996 17:42 KHIS REGULATORY +001 214 994 4100 P.05
NOV 14 1996 K961739
# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
I. DATE PREPARED: April 30, 1996
Revised: November 11, 1996
II. SUBMITTER:
Eastman Kodak Company
Health Imaging Division
18325 Waterview Parkway
Dallas, Texas 75252-8026
III. CONTACT PERSON:
Nancy Butcher
Regulatory Affairs
(214) 454-1417
IV. DEVICE NAME:
Trade Name: KODAK Digital Science Medical Modality Acquisition Unit (K961739)
Common Name: Picture Archiving and Communications Systems (PACS) Components
V. DEVICE CLASSIFICATION
FDA has classified the predicate device as Regulatory Class II under 21 CFR 892.1750.
VI. PREDICATE DEVICE:
KODAK Ektascan Imagelink System
VII. DESCRIPTION OF DEVICE:
The KODAK Ektascan Imagelink System [KEIS] is composed of components common to all image management systems for image acquisition, printing, review, archive/retrieval, and communications. These components can be combined into customized solutions for the management of diagnostic image information. Evaluation of soft and or hard copy output provides adequate opportunity for competent human intervention.
13
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NOV-06-1996 17:43 KHIS REGULATORY +001 214 994 4122 5.05
## VIII. INDICATIONS FOR USE:
The KODAK Ektascan Imagelink System (KEIS) is a DICOM conferment product designed for use within a Picture Archiving and Communication System (PACS).
The KODAK Ektascan Imagelink System is composed of two major components, the KODAK Digital Science Medical Modality Acquisition Unit and the KODAK Digital Science Medical Printer Interface Unit. These systems can exit together or independently on a network.
## V. COMPARISON OF FEATURES:
### SIDE-BY-SIDE COMPARISON TABLE
| Characteristics | KODAK Digital Science Medical Modality Acquisition Unit and Printer Interface Unit | KODAK Ektascan Imagelink System |
| --- | --- | --- |
| K number | this submission | K931551 |
| GENERAL | | |
| Advertised use | Productivity improvement, eliminate film cassettes and darkroom processing, eliminate need to sterilize film cassettes | Productivity improvement, eliminate film cassettes and darkroom processing, eliminate need to sterilize film cassettes |
| Input modalities advertised | C-Arm, Digital Subtraction Angiography, Nuclear Medicine, Ultrasound, and other video modalities. | C-Arm, Digital Subtraction Angiography, Nuclear Medicine, and Ultrasound |
| Power requirements | 90-132vac/47-63Hz
180-264vac/47-63Hz | 90-132vac/47-63Hz
180-264vac/47-63Hz |
| Environmental | 4-45 degrees C/15-90% RH non-condensing | 4-45 degrees C/15-90% RH non-condensing |
| Acquisition Unit | | |
| Removable Disk | 2.5" Hard Drive | 2.5" Hard Drive |
| Disk Storage Capacity | 105, 30, 60, 80 Mbytes | 30, 60 Mbytes |
| Network Capability | Ethernet | Ethernet |
| Video Inputs | Monochrome: RS-170/CCIR; Red, Green, Blue (RGB) | Monochrome: RS-170/CCIR; Red, Green, Blue (RGB) |
| Image Capture Time | 1/30 second | 1/30 second |
| Image Store Time | Less than 1 second | Less than 1 Second |
| Printer Interface Unit | | |
| Inputs | Removable Disk Cartridge, Ethernet, DICOM v3.0 format (ACR_NEMA) | Removable Disk Cartridge, Ethernet, DICOM v3.0 format (ACR_NEMA) |
| Outputs | SCSI, Video, RS-485, RS-422, RS-232 | SCSI, Video, RS-485, RS-422, RS-232 |
| Image Presentation | 1,2,4,6,8,9,12,15,16,24,35 images per frame, plus slides | 1,2,4,6,8,9,12,15,16,24,35 images per frame, plus slides |
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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.
