AMICAS PACS 6.0 is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, to include Digital Mammography. AMICAS PACS 6.0 receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems. AMICAS PACS 6.0 imports images and render said images, upon request, within the viewer component utilizing both lossless (reversible) and lossy (irreversible) compression. To support the diagnostic interpretation of Mammography studies, AMICAS PACS 6.0 will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images must not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Within AMICAS PACS 6.0, the AMICAS Real Time Worklist offers real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, and configurable, components within the Real Time Worklist. AMICAS PACS 6.0 also offers the Patient Dashboard which provides a single view of all patient data, both imaging and non-imaging. AMICAS Reach is an optional component within AMICAS PACS 6.0 which provides clinicians secure, proactive communication and access to clinical reports and images. Order and Report information generated by HIS/RIS and report creation systems are received and displayed in PACS via the transmission of HL7 messaging. For this data, AMICAS PACS 6.0 is not the creator, but instead the downstream recipient which relies on the validity of data from said systems. AMICAS PACS 6.0 must be installed on suitable, commercial-standard hardware. It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.
Device Story
Software-based Picture Archiving and Communication System (PACS); receives DICOM-compliant images from imaging modalities and FDA-cleared CAD/image processing systems; imports and renders images for soft copy reading; supports lossless/lossy compression; displays full-fidelity DICOM for mammography. Features include Real Time Worklist for workflow management, Patient Dashboard for consolidated patient data, and AMICAS Reach for secure clinician communication. Receives HIS/RIS data via HL7. Operated by radiologists, technologists, and clinicians in clinical settings. Provides tools for image manipulation (enlarging, highlighting, obscuring). Output used by clinicians for diagnostic interpretation; supports clinical decision-making by providing access to images and reports. Benefits include centralized data management, workflow efficiency, and secure communication of critical results.
Clinical Evidence
Bench testing only. Functional verification performed per Software Requirements Specifications. Design validation conducted in real-life client environments by licensed physicians to assess intended use, end-user expectations, and experience. No clinical trial data presented.
Technological Characteristics
Software-based PACS; runs on commercial-standard hardware. Supports DICOM (images, CAD Structured Reports, Grayscale SoftCopy Presentation State) and HL7 (HIS/RIS data). Features lossless/lossy compression. Requires FDA-cleared 5Mpixel monitors for mammography. Connectivity: Networked. Sterilization: N/A (software).
Indications for Use
Indicated for soft copy reading, communication, and storage of digital medical images, including digital mammography. Intended for use by radiologists, technologists, and clinicians. Contraindicated for primary diagnosis using lossy compressed mammography images or digitized film screen images.
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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AMICAS PACS 6.0 510(k)
## 510(k) Summary of Safety and Effectiveness - as required by 21 CFR part 807.92
Date prepared:
July 24, 2008
Submitted by:
AMICAS, Inc. 20, Guest St. Suite 400 Boston, MA 02135
Contact: Contact email: Contact Telephone: Contact Fax:
Device Trade Name: Device Common Name: Regulation number: Device Classification: Name: Predicate Device: Predicate Device Manufacturer:
Predicate Device 510(k) number: Date received: Decision date: Decision: Panel Code Device reviewed by: Panel Code Device classified by: Product Code: Regulation number: Device Classification:
Patrice JC Nedelec pnedelec@amicas.com 617-779-7858 or 617-372-1331 732-601-2512
AMICAS PACS 6.0 Picture Archiving Communication System (PACS) 892.2050 Class II AMICAS PACS AMICAS Vision Series PACS 5.5 AMICAS Inc. 20 Gucst Street Boston, MA 021235 K073526 12/17/2007 03/12/2008 Substantially equivalent Radiology Radiology LLZ 892.2050 Class II
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#### Device Description, intended use
AMICAS PACS 6.0 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 AMICAS PACS 6.0 are radiologists, technologists and clinicians.
AMICAS PACS 6.0 is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, to include Digital Mammography. AMICAS PACS 6.0 receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDAcleared Image processing systems.
AMICAS PACS 6.0 imports images and render said images, upon request, within the viewer component utilizing both lossless (reversible) and lossy (irreversible) compression.
To support the diagnostic interpretation of Mammography studies. AMICAS PACS 6.0 will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images must not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA,
Within AMICAS PACS 6.0, the AMICAS Real Time Worklist offers real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, and configurable, components within the Real Time Worklist.
AMICAS PACS 6.0 also offers the Patient Dashboard which provides a single view of all patient data, both imaging and non-imaging.
AMICAS Reach is an optional component within AMICAS PACS 6.0 which provides clinicians secure, proactive communication and access to clinical reports and images.
Order and Report information generated by HIS/RIS and report creation systems are received and displayed in PACS via the transmission of HL7 messaging. For this data, AMICAS PACS 6.0 is not the creator, but instead the downstream recipient which relies on the validity of data from said systems.
AMICAS PACS 6.0 must be installed on suitable, commercial-standard hardware. It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.
Part B: Administrative Information - Section A: 510(k) Summary of Safety and effectiveness Page 2 of 3
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#### General Safety Considerations
AMICAS PACS 6.0 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.
AMICAS PACS 6.0, as its predicate, 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
AMICAS PACS 6.0 is tested with reference to its Software Requirements Specifications, as documented in the Functional Verification Procedure included in this 510(k) filing.
Functional testing is an integral part of AMICAS, Inc. Product Development process known as "VDEV" (Vision Development Elaboration Validation), also documented in this filing (see part G section B).
Before undergoing Functional testing, a PACS application undergoes technical, lowerlevel testing known as "Unit Testing"; related verification, test cases and results are as well documented in this 510(k) filing (see part G section I).
Design Validation activities, as depicted in Part D of this filing, consist of testing in reallife client environments by Licensed Physicians, and address intended use, end-user expectations and experience.
The AMICAS Quality Department, per procedure, independently verifies completeness of all deliverables -to include testing reports and assessment of safety and effectiveness as well as Risk Analysis Record- before issuing a recommendation to release to Management.
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#### Some more detail on CAD SR support and GSPS
CAD (Computer Aided Detection), or more specifically "Mammo CAD Markers" are generated by 3rd party Medical Devices approved by FDA. They are in the form of nonimage DICOM Structured Reports (S/R) and contain vector and text information that is rendered on the image, to show possible areas of concern. The workflow is that the images (study) are captured and imported into the AMICAS system from the imaging modality, and in parallel, the images (study) are also sent to CAD for processing. The output of these the CAD systems are non-imaging DICOM S/R files that also get imported into the AMICAS system.
When the user loads a study, we display the images as we normally do, and provide indicators on the images if these CAD are available. The CAD markers are not displayed initially, only after the user has viewed the images. These markers can be manually turned on.
GSPS (Grayscale SoftCopy Presentation State) is a non-image DICOM format. By default, the initial presentation state of images are derived from a limited number of DICOM tags (such as the initial Window/Level values, or LUT (look up table). GSPS is a much more general format, which provides for many presentation (rendering) parameters (window/level, LUTs, zoom/pan, invert, and orientation) as well as annotations. AMICAS PACS 6.0 uses GSPS objects for our native format, for the rendering parameters as well as annotations. It is possible to take our generated GSPS objects and use them to display it exactly as it appears in AMICAS PACS 6.0 on any DICOM compliant device, assuming it supports GSPS.
Mammography workstations were probably the first to start to use GSPS. It is also the basic of IHE CPI (Consistent Presentation of Images) Profile, so any DICOM device that generates GSPS object can be used as input into our server for studies we display.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol with three curved lines, resembling a person with outstretched arms. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
### DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Patrice J.C. Nedelec Director of Quality AMICAS, Inc. 20 Guest Street Suite 400 BOSTON MA 02170
Re: K082144
Trade/Device Name: AMICAS PACS 6.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 28, 2008 Received: July 30, 2008
Dear Ms. Nedelec:
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 such 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.
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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.
This letter will allow you to begin 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C Brogdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
.
Enclosure
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# Indications for Use
510(k) Number (if known):
Device Name: AMICAS PACS 6.0
Indications For Use:
AMICAS PACS 6.0 is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, to include Digital Mammography. AMICAS PACS 6.0 receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems.
AMICAS PACS 6.0 imports images and render said images, upon request, within the viewer component utilizing both lossless (reversible) and lossy (irreversible) compression. To support the diagnostic interpretation of Mammography studies, AMICAS PACS 6.0 will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images must not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Within AMICAS PACS 6.0, the AMICAS Real Time Worklist offers real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, and configurable, components within the Real Time Worklist.
AMICAS PACS 6.0 also offers the Patient Dashboard which provides a single view of all patient data, both imaging and non-imaging.
AMICAS Reach is an optional component within AMICAS PACS 6.0 which provides clinicians secure, proactive communication and access to clinical reports and images.
Order and Report information generated by HIS/RIS and report creation systems are received and displayed in PACS via the transmission of HL7 messaging. For this data, AMICAS PACS 6.0 is not the creator, but instead the downstream recipient which relies on the validity of data from said systems.
AMICAS PACS 6.0 must be installed on suitable, commercial-standard hardware. It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.
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Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Hut Leeee
(Division Sign-Off) Division of Reproductive, Abdominal 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.
