eRAD PACS is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. eRAD PACS is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
Device Story
eRAD PACS is a Picture Archiving and Communication System (PACS) and teleradiology platform. It receives DICOM images, scheduling information, and textual reports from various sources. The system architecture includes acquisition components (GatewayServer, SendServer), a central system manager (SmartServer), diagnostic workstations (Workstation and Viewer), and an archiving component (ArchiveServer). Data is registered, stored in an internal format, and made accessible across networks via web and customized interfaces. Radiologists and clinicians use the diagnostic workstation to view images and dictate reports, which are then transcribed and stored. The system facilitates clinical decision-making by providing authorized users with centralized access to patient images and reports. It is intended for use in clinical environments such as hospitals and imaging centers.
Clinical Evidence
No clinical data provided. The submission relies on bench testing and functional verification of software components to demonstrate substantial equivalence.
Technological Characteristics
PACS system utilizing off-the-shelf computer hardware. Components include GatewayServer, SendServer, SmartServer, ArchiveServer, and diagnostic workstations. Connectivity via network using DICOM standards. Software-based image management and display system.
Indications for Use
Indicated for use in hospitals, imaging centers, and radiologist reading practices to manage, store, and display DICOM images, scheduling data, and textual reports for authorized users requiring access to patient demographic and clinical information.
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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# Ko 6 142 1
# 510(k) SUMMARY
In accordance with the provisions of the Safe Medical Device Act of 1990, eRAD Inc. In accordance with the providing a summary of safety and effectiveness information (Image Medical Solp); (18 providure Archiving and Communications System.
### Company Identification 1.1
eRAD Inc. (Image Medical Corp.) 9 Pilgrim Road Greenville SC 29607. Establishment Registration: 2954766 Owner Operator Number: 9042966 Contact: Jim Connors, Vice President, Product Management Tel: (864) 640-8664 Fax: (864) 234-7412
#### Official Correspondent 1.2
Gary J. Allsebrook, Consultant Regulatory Management Services 16303 Panoramic Way San Leandro CA USA 94578-1116 Tel/fax: (510) 276-2648 Cell: (510) 388-5001 Email: regman10@comcast.net
#### 1.3 Date of Submission
May 16, 2006
#### Device Name 1.4
Classification Name: Common/Usual Name: Proprietary Name:
PACS Soft-copy reading and acquisition system eRAD PACS
### Substantial Equivalence 1.5
eRAD PACS has indications for use and a target population similar to other medical image management devices, including Stentor's iSite (K013630) and modioal Thage Thanag Thanas (K022292), Ultravisual's Vortex (K012097) and Dynamic Imaging's INTEGRADWeb MPR/MIP (K042313). All of the functions eRAD PACS performs are available in at least one of the listed the fanctially equivalent devices. In most cases, the function is available in all of
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There are no significant differences between eRAD PACS and the them. collective functions of all the predicate devices.
### Device Description and Intended Use 1.6
eRAD PACS is a PACS system, comprised of acquisition components (GatewayServer and SendServer), a central system manager component (SmartServer), a diagnostic workstation component (Workstation and Viewer), (and an archiving component (ArchiveServer). The data flow is such that patient and on and is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. After receiving the procedure information or after receiving image objects, the central system manager information of and retrieves relevant procedure data from the archive component. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the item from the operator worklist. The image data is transmitted to by oreading and the user's workstation using the diagnostic workstation components. After using the workstation to view the images, the user optionally dictates a report into the system, after which, a user can play back the dictation and transcribe it to text. Once eRAD PACS's central system manager registers a and the report is available for access by the referring physician, or it can be exported into an information system. At some configured point in time, the image data and the report information is delivered to the archiving component for backup and long-term storage.
eRAD PACS is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in internal format, and to make that information available across a network via web and customized user interfaces. eRAD PACS is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
#### Software Development 1.7
eRAD Inc., certifies that the eRAD PACS software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field
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maintenance. The software developed for this product is used to provide diagnostic quality images and associated information for the intended users.
### Safety and Effectiveness 1.8
## General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and any warnings or cautions to rrovide for the safe and effective use of the device. It is the user's responsibility to insure that display quality, environmental lighting and other possible distractions are consistent with a clinical environment. The hardware components specified are all "off the shelf" computer components.
It is our conclusion that there is no software or hardware component in the eRAD It is our over which would be used in conjunction with the eRAD PACS device, that we know of, whose failure or latent design flaw would be expected to result in death or injury to a patient. Thus the "level of concern" on the eRAD PACS device is "minor".
# Substantial Equivalence Summary:
eRAD PACS is substantially equivalent in design and intended use to diagnostic workstations, PACS and image management systems and substantiated in the feature comparison. Any differences between the eRAD PACS and the predicate devices have no significant influence on safety and effectiveness. eRAD PACS, therefore, raises no new issues of safety or effectiveness from the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 25 2006
eRad, Inc. % Mr. Gary J. Allsebrook Consultant Regulatory Management Services 16303 Panoramic Way SAN LEANDRO CA 94578
Re: K061421
Trade/Device Name: eRAD PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 19, 2006 Received: May 22, 2006
Dear Mr. Allsebrook:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/10 description: The image shows a circular logo with the letters "FDA" in a stylized font at the center. Above the letters, the years "1906 - 2006" are printed, indicating a centennial celebration. Below the letters, the word "Centennial" is written in a cursive font, and three stars are aligned beneath it. The logo has a dotted border, giving it a stamp-like appearance.
Protecting and Promoting Public Health
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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ペυω ノナ2/
eRAD, Inc (Image Medical Corp.) eRAD PACS Device Name: Picture Archiving and Communications System
Indications For Use:
eRAD PACS is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. eRAD PACS is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
# (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 901.109)
OR
Over-the-Counter Use
Harvey Clayton
(Division Sign-Off)
Division of Reproductive, Andominal and Radiological Devices
510(k) Number ________________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
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.
