K022970 · Amicas, Inc. · LLZ · Nov 22, 2002 · Radiology
Device Facts
Record ID
K022970
Device Name
AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0
Applicant
Amicas, Inc.
Product Code
LLZ · Radiology
Decision Date
Nov 22, 2002
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The AMICAS Diagnostic Workstation (ADW) is software intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard hardware. The ADW receives imaging studies over a network from AMICAS servers or directly from CD with images utilizing both lossless (reversible) and lossy (irreversible) compression. It is the user's responsibility to ensure that monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.
Device Story
Software-based diagnostic workstation for viewing/interpreting DICOM-compliant medical images (CT, MR, CR, DR, US). Inputs received via network from servers or CD; supports lossless and lossy JPEG2000 compression. Provides tools for multi-planar reformatting, volume rendering, maximum intensity projection, image measurement, and editing. Operated by radiologists, technologists, and clinicians on commercial-standard hardware. Output displayed on monitors for clinical diagnostic decision-making. Benefits include enhanced visualization of anatomy through 2D/3D reconstruction and efficient image management.
Clinical Evidence
Bench testing only. Verification performed against Software Requirements Specifications. Functional testing conducted as part of the product development process.
Technological Characteristics
Software-only diagnostic workstation. Operates on commercial-standard computer hardware. Supports DICOM image data. Features include multi-planar reformatting, volume rendering, maximum intensity projection, and JPEG2000 compression (lossless/lossy).
Indications for Use
Indicated for viewing and diagnostic interpretation of medical images (CT, MR, CR, DR, US) by radiologists, technologists, and clinicians.
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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022970
## 510(k) Summary of Safety and Effectiveness - as required by section 807.92(c)
| Date prepared: | September 1, 2002 | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Submitted by: | Amicas, Inc.<br>20, Guest St.<br>Boston, MA 02135 | |
| Contact:<br>Contact email:<br>Contact Telephone:<br>Contact Fax: | Patrice Nedelec<br>pnedelec@amicas.com<br>617-779-7858<br>617-783-7209 or 617-779-7879 | |
| Device Trade Name:<br>Device Common Name:<br>Regulation number:<br>Device Classification:<br>Name:<br>Predicate Device:<br>Predicate Device Manufacturer: | Amicas Light Beam Workstation<br>Picture Archiving Communication System (PACS)<br>892.2050<br>Class II<br>Diagnostic Workstation<br>Voxar Plug'n View 3D, Version 1.0<br>Voxar Limited<br>Bonnington Bond<br>2 Anderson Pl.<br>Edinburgh, UK EH6 5NP | |
| Predicate Device 510(k) number:<br>Date received:<br>Decision date:<br>Decision:<br>Panel Code Device reviewed by:<br>Panel Code Device classified by:<br>Product Code:<br>Regulation number:<br>Device Classification: | K992654<br>08/09/1999<br>11/05/1999<br>Substantially equivalent<br>Radiology<br>Radiology<br>LLZ<br>892.2050<br>Class II | |
Device Description and intended use:
AMICAS Light Beam Workstation (ALBW) is software intended to create and display two-dimensional and three-dimensional images of anatomy from a series of digitally acquired images.
Typical users of ALBW are radiologists, technologists and clinicians.
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| Feature | ALBW | Voxar Plug'n View 3D<br>version 1.0 |
|----------------------------------|------|-------------------------------------|
| Software Only | Yes | Yes |
| Image Measurements | Yes | Yes |
| Multi-planar reformatting | Yes | Yes |
| Volume Rendering | Yes | Yes |
| Maximum Intensity | Yes | Yes |
| Projection | Yes | Yes |
| Image editing | Yes | Yes |
| Printing | Yes | Yes |
| DICOM Images | Yes | Yes |
| Lossless JPEG2000<br>Compression | Yes | No |
| Lossy JPEG2000<br>Compression | Yes | No |
Technological characteristics:
General Safety Considerations
ALBW software and the computer platform that it is installed on together constitute a system for the interpretation of medical image data by trained and qualified professionals. It is the user's responsibility to ensure that image quality, display quality, environmental lighting and other possible distractions are consistent with the clinical application. Refer to the instruction manuals for your specific computer and display hardware for information regarding installation, calibration and additional safety issues.
The ALBW includes tools for enlarging, highlighting and obscuring portions of an image relative to other portions. Inappropriate application of these tools can result in the obscuration of important anatomy and contribute to an erroneous interpretation. It is the user's responsibility to understand the effect of image manipulation tools and to apply in a manner consistent with the clinical application. The user must review the cautionary statements in the User's guide.
Be sure to limit access to patient data to authorized individuals who are fully trained and qualified to use this equipment.
## Testing:
ALBW is tested with reference to its Software Requirements Specifications, as documented in the Verification Procedure included in this 510(k) filing. Functional testing is an integral part of Amicas, Inc. Product Development process, also included in this filing (see section G)
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing right, with flowing lines above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2002
Mr. Patrice Nedelec Director, Quality Assurance and Regulatory Affairs Amicas, Inc. 20 Guest St. BOSTON MA 02135
Re: K022970
Trade/Device Name: Amicas Light Beam Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: September 1, 2002 Received: September 6, 2002
Dear Mr. Nedelec:
This letter corrects our substantially equivalent letter of November 22, 2002, regarding the incorrect address.
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 iddications for use stated in the enclosure) to legally marketed predicate devices marketed in interent commerce prior to May 28, 1976, the enactment date of the Medical Device Amendmint or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drig and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You, Diug, therefore, market the device, subject to the general controls provisions of the Act. The greneral 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 an 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. Your must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Mr. Nedelec
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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
David A. Sezmann
Nora S. Bozeman
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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Page 1 of 1
510(k) Number (if known): Ko22970
Device Name: Amicas Light Beam Workstation
Indications For Use:
The AMICAS Diagnostic Workstation (ADW) is software intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard hardware. The ADW receives imaging studies over a network from AMICAS servers or directly from CD with images utilizing both lossless (reversible) and lossy (irreversible) compression. It is the user's responsibility to ensure that monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional format 3-10-98)
*Prescription Use*
Daniel G. Loomis
(Division Sign-Off) Division of Reproductive, Abdon and Radiological Device 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.
