eFilm™ Workstation is a software application that is used for viewing medical images. eFilm™ Workstation receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm™ Workstation can be integrated with an institution's existing HIS or RIS for a fully integrated electronic patient record. Typical users of eFilm™ Workstation are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
Device Story
eFilm™ Workstation is a PACS software application for viewing and processing medical images. It receives digital image data (DICOM 3.0) from various imaging modalities (CT, MR, US, RF, etc.) via network or local storage. The software provides tools for image manipulation, including window/level adjustment, stacking, annotation, measurement, inversion, rotation, and flipping. It integrates with existing HIS/RIS systems. Operated by trained medical professionals (radiologists, clinicians, technologists) in clinical settings, the device displays images on a workstation. It does not contact the patient or control life-sustaining equipment; it relies on human interpretation of the displayed information to support clinical decision-making.
Clinical Evidence
Bench testing only. The submission relies on software development process documentation (SOP-01) and hazard analysis to demonstrate safety and effectiveness. No clinical data provided.
Technological Characteristics
Software-based PACS application; DICOM 3.0 compliant; supports network-based image transmission and local storage; hardware-agnostic; provides image processing (window/level, annotation, measurement, rotation/flip); no patient contact; no life-sustaining control functions.
Indications for Use
Indicated for trained medical professionals (radiologists, clinicians, technologists) to view, store, communicate, process, and display medical images from various sources (CT, MR, US, RF, CR/DR, scanners) for diagnostic purposes.
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
RadWorks™ Medical Imaging Software with Quality Control Module (K982862)
Submission Summary (Full Text)
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# JUL 3 1 2001
K012211
## 510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness is provided as part of the Premarket Notification for eFilm™ Workstation, in accordance with SMDA 1990.
| Date Prepared: | July 4, 2001 |
|----------------------------------|---------------------------------------------------------------------------------------------|
| Submitted By: | eFilm™ Medical Inc.<br>500 University Ave, Suite 300,<br>Toronto, Ontario<br>Canada M5G 1V7 |
| Contact Name: | Kathy Chin |
| Contact Email: | kathy.chin@efilm.ca |
| Contact Telephone: | (416) 204 9664 ext 222 |
| Contact Fax: | (416) 204 9442 |
| Device Trade Name: | eFilm™ Workstation |
| Device Common Name: | Picture Archiving Communications System (PACS) |
| Device Classification: | 892.2050 (Class II) |
| Name: | Image Processing System |
| Predicate Device: | RadWorks™ Medical Imaging Software with Quality<br>Control Module |
| Predicate Device Manufacturer: | Applicare Medical Imaging B.V. |
| Predicate Device 510(k) Number: | K982862 |
| Date Received: | 08/13/1998 |
| Decision Date: | 10/21/1998 |
| Decision: | Substantially Equivalent |
| Panel Code Device Reviewed by: | Radiology |
| Panel Code Device Classified by: | Radiology |
| Product Code: | LLZ |
| Classification: | 892.2050 (Class II) |
#### Device Description
eFilm™ Workstation is one of the components of a PACS (Picture Archiving and Communications System). eFilm™ Workstation is a software application that provides image viewing and System). Chim - Wonotion 10 a setting. The functions of this application are applied to medical images that are acquired and stored on an image server in DICOM and/or other modioal integor that an also transfer DICOM 3.0 images over a medical imaging network, as well as export images to applications in other proprietary formats.
#### Indications For Use
eFilm™ Workstation is a software application that is used for viewing medical images. eFilm™ Workstation receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of
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interest; and inversion, rotation, and flips of images. In addition, eFilm™ Workstation can be interest, and litverolori, forcation, this or RIS for a fully integrated electronic patient record.
Typical users of eFilm™ Workstation are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
#### Technological Characteristics
Both the eFilm™ Workstation and the Radworks™ Medical Imaging Software with Quality Control Bon the on intentioners packages which can be used on more than one hardware Moduc are other alone benefits before requirements are met, the user is free to choose his/her own hardware platform.
Both systems allow digital image processing and measurement capability. Both systems can transmit to remote viewing stations over a medical imaging network.
eFilm™ Workstation does not contact the patient, nor does it control any life-sustaining devices. e int" wontetation associety for competent human intervention interprets images and information being displayed and/or printed.
#### Testing
eFilm™ Workstation is tested according to the specifications that are documented in a Software of mr. Testing is an integral part of eFilm Medical Inc.'s software development process as described in the SOP-01: Product Development Process
#### Conclusion
The 510(k) premarket notification for eFilm™ Workstation contains adequate information and data to enable FDA-CDRH to determine substantial equivalence to the predicate device.
- 1. eFilm™ Workstation has been and will continue to be manufactured according to the voluntary standards listed in the Voluntary Standards section (4.1) of this submission.
- 2. This submission contains the result of a hazard analysis and all potential hazards have been classified as minor.
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 1 2001
eFilm Medical, Inc. % Mr. N.E. Devine, Jr. Responsible Third Party Offical Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548
Re: K012211
eFILMTM Workstation (PACS) Dated: July 4, 2001 Received: July 16, 2001 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Devine:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the We meversions your booking of or the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce pror 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, that neve room recentise in about 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 (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, to such additions of the minute the equivalent determination assumes compliance with the Current Good Manufacturing The 21, 1 at 5 oo to 093. I Fouromation (QS) for Medical Devices: General regulation (QS) for Medical Devices (21 CFR Part I have 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 to comply frial also are the Federal Register. Please note: this response to your premarket notification submission does not ection any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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) 594-4639. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours
Nancy C. Bogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure (s)
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## Indications For Use Statement
510(k) Number: K012211
## Device Name: eFilm™ Workstation
#### Indications for Use:
eFilm™ Workstation is a software application that is used for viewing medical images. eFilm™ Workstation receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm™ Workstation can be integrated with an institution's existing HIS or RIS for a fully integrated electronic patient record.
Typical users of eFilm™ Workstation are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
## (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109):
→
OR
Over the Counter Use (optional Format 1-2-96): __
Ohrid L. Ingram
(Division Sign-Division of Reproductive, Abdomin 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.
