RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE
K982862 · Applicare Medical Imaging, B.V. · LLZ · Oct 21, 1998 · Radiology
Device Facts
Record ID
K982862
Device Name
RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE
Applicant
Applicare Medical Imaging, B.V.
Product Code
LLZ · Radiology
Decision Date
Oct 21, 1998
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The RadWorks Medical Imaging Software, from Applicare Medical Imaging, B.V., when installed on an appropriate hardware platform, is intended to provide capability for the acceptance, display, storage, and digital processing of medical images. Options allow for additional capability, including transmission of images over local area networks or public communications channels, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality control review and revision of studies.
Device Story
RadWorks Medical Imaging Software with Quality Control Module; software-based system for medical image management. Inputs: digital images from medical modalities; film images via digitization. Operations: acceptance, display, storage, digital processing, and quality control review. QC functions: confirm/edit patient characteristics, review study history, add/remove images, combine studies, renumber images, edit orientation, set routing. Used by authorized staff in clinical environments. Output: processed/managed imaging studies for network distribution. Benefits: ensures data integrity and study organization before clinical availability.
Clinical Evidence
Bench testing only. Software testing followed internal procedures, including development of a test plan, documentation of test procedures, expected results, and recording of results.
Technological Characteristics
Software-based digital image communications system. Operates on appropriate hardware platforms. Functions include image acceptance, display, storage, processing, and network transmission. No specific hardware materials or energy sources defined beyond standard computing equipment.
Indications for Use
Indicated for use by authorized staff to perform quality control operations on medical imaging studies, including patient data verification, image management, and routing, prior to network distribution.
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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K982862
# 510(k) Summarv
# RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE
Common/Classification Name: Digital Image Communications System
Applicare Medical Imaging, B.V. P. O. Box 936 3700AX Zeist The Netherlands +31-30-6926000 FAX +31-30-6926010
> Contact: Bernie van Welt Prepared: July 6, 1998
# LEGALLY MARKETED PREDICATE DEVICES A.
The RadWorks Medical Imaging Software with Quality Control Module is substantially equivalent to the original version of the RadWorks Medical Imaging Software (K962699).
#### DEVICE DESCRIPTION B.
The RadWorks Quality Control Module is intended to be used by authorized staff to perform various quality control operations on RadWorks imaging studies before they are made available to other locations on the network. These operations include confirming or editing patient characteristics, reviewing the status history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.
#### C. INTENDED USE
The RadWorks Quality Control Module is intended to be used by authorized staff to perform various quality control operations on RadWorks imaging studies before they are made available to other locations on the network. These operations include confirming or editing patient characteristics, reviewing the status history of the study, adding or removing images, combining with another study, renumbering images, editing patient orientation information, and setting or editing routing information.
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# D. TECHNOLOGICAL CHARACTERISTICS
The technological characteristics of the modified device are identical to those of the original device.
## E. TESTING
Software testing of the new module followed Applicare's normal procedures. During the design phase, a software test plan is developed, containing a detailed description of relevant test procedures. Each test procedure is documented and contains a description of what to test, what the expected results are, when to test, by whom the tests will be performed, which resources (such as automated test tools) will be used and how the test results are recorded.
### F. CONCLUSIONS
In summary, Applicare has demonstrated that the intended use for RadWorks Medical Imaging Software with Quality Control Module is the same as that of the original (predicate) device, and the technological characteristics have been described in sufficient detail to demonstrate that they are the same as those of the predicate device. Therefore, this premarket notification has demonstrated Substantial Equivalence as defined and understood in the Food, Drug, & Cosmetic Act and its amendments.
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Image /page/2/Picture/0 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
Applicare Medical Imaging, B.V. c/o T. Whit Athey, Ph.D. C.L. McIntosh & Associates 12300 Twinbrook Parkway, Suite 625 Rockville, MD 20852
K982862
Re:
RadWorks Medical Imaging Software with Quality Control Module Dated: August 13, 1998 Received: August 13, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Dr. Athey:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the exclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice Jabeling; 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Modisol Devices» General regulation (21 CFR Part 820) and that, through periodic OS 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 concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect 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(1) 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 80V-and additionally 809.10 for in ritin diagnostic devices), please contact the Office of Compliance at (301) 594-4643. 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 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/odrf/dsma/dsmamain.html".
Sincerely yours,
William Yip, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K (332862
Device Name: RadWorks Medical Imaging Software with Quality Control Module
Indications For Use:
The RadWorks Medical Imaging Software, from Applicare Medical Imaging, B.V., when installed on an appropriate hardware platform, is intended to provide capability for the acceptance, display, storage, and digital processing of medical images. Options allow for additional capability, including transmission of images over local area networks or public communications channels, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality control review and revision of studies.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel C. Bergman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
Prescription Use
(Per 21 CFR 801.109)
OR
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.
