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 Description

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.

AI/ML Overview

This document describes the eRAD PACS (Picture Archiving and Communications System), a medical device intended for managing and displaying medical images and related information. However, the provided text does not contain information about specific acceptance criteria for device performance, nor does it describe any study (clinical or otherwise) that proves the device meets such criteria.

The document focuses on:

Company Identification and Submission Details: Basic administrative information.
Device Name and Substantial Equivalence: Classifies the device as a PACS soft-copy reading and acquisition system and asserts its substantial equivalence to other legally marketed PACS devices (Stentor's iSite, Toshiba's TICS, Ultravisual's Vortex, Dynamic Imaging's INTEGRADWeb MPR/MIP).
Device Description and Intended Use: Explains the components and workflow of eRAD PACS (acquisition, central system manager, diagnostic workstation, archiving) and its purpose in hospitals, imaging centers, and radiology practices.
Software Development: States that the software is designed, developed, tested, and validated according to written procedures.
Safety and Effectiveness: Claims that the device has a "minor" level of concern and raises no new safety or effectiveness issues compared to predicate devices.
FDA Communication: A letter from the FDA confirming the device's substantial equivalence and permitting its marketing.

Therefore, based solely on the provided text, I cannot provide the requested information regarding acceptance criteria or the study proving their fulfillment. The document does not describe:

A table of acceptance criteria and reported device performance: No specific performance metrics (e.g., image quality, processing speed, diagnostic accuracy) or their targets are mentioned.
Sample size for the test set and data provenance: No test sets, patients, or images used for evaluation are described.
Number of experts and their qualifications for ground truth: No expert involvement in establishing ground truth is mentioned.
Adjudication method for the test set: No adjudication process is described.
MRMC comparative effectiveness study: No study involving human readers with or without AI assistance is mentioned.
Standalone performance study: No study evaluating the algorithm's performance independent of human readers is described.
Type of ground truth used: No mention of expert consensus, pathology, or outcomes data being used as ground truth.
Sample size for the training set: No training set or its size is mentioned.
How ground truth for the training set was established: Not applicable, as no training set is mentioned.

The document discusses "testing" and "validation" as part of software development, but it does not detail the nature of these tests, their specific objectives, the data used, or the performance metrics achieved. It primarily focuses on the device's functional equivalence to existing PACS systems and adherence to general safety and software development practices.

Summary

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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 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:

(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)

Over-the-Counter Use

Harvey Clayton
(Division Sign-Off)

Division of Reproductive, Andominal and Radiological Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).