(49 days)
Not Found
No
The summary describes a standard PACS system for image management, storage, and viewing. There is no mention of AI, ML, or any advanced image processing or analysis features that would typically indicate the use of such technologies.
No.
The device is a PACS system designed for managing and viewing medical images and reports, not for directly treating or diagnosing medical conditions.
No
The device is a PACS system designed for managing, storing, and making medical images and reports available. While it includes a "diagnostic workstation component" for viewing images, its primary function is data management and display, not to perform a diagnosis itself or process images for diagnostic purposes. Its intended use is to provide access to information for professionals who then perform diagnostic interpretation.
No
The device description explicitly mentions "acquisition components," "central system manager component," "diagnostic workstation component," and "archiving component," which are described as parts of the system and imply hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a PACS and teleradiology system used for receiving, organizing, storing, and making available medical images, scheduling information, and textual reports. It is for use by hospitals, imaging centers, and radiologist reading practices for accessing patient image, demographic, and report information.
- Device Description: The description details the components and data flow of a PACS system, focusing on image acquisition, storage, retrieval, viewing, and reporting.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. IVDs are typically used in laboratories or point-of-care settings for analyzing biological samples.
This device falls under the category of medical image management and viewing systems, which are distinct from IVD devices.
N/A
Intended Use / Indications for Use
Advanced 3D Web PACS™ is a PACS and teleradiology system used to receive DICOM and other medical 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. Advanced 3D Web 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,
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammodraphic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Advanced 3D Web PACS™ is a PACS system, comprised of acquisition components (Medweb secure DICOM Proxy Web Server, ), a central system manager component (Medical Transcription Server), a diagnostic workstation component (Radiologist Dashboard©), and an archiving component (DICOM Archive). The data flow is such that patient and procedure information 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 searches for and retrieves relevant prior 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 work list. The image data is transmitted to and rendered on 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 Advanced 3D Web PACS™ central system manager registers a report, 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.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA
Advanced 3D Web 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DICOM images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
322
510(k) SUMMARY
In accordance with the provisions of the Safe Medical Device Act of 1990. Nexsys, Inc., dba Medweb, LLC, is providing a summary of safety and effectiveness information regarding the Advanced 3D Web PACS™ , Picture Archiving and Communications System.
1.1 Company Identification
Establishment Registration: 2953193 Owner Operator Number: 9017001 Nexsys Electronics, Inc. dba Medweb LLC 667 Folsom St. San Francisco CA 94107 Contact: Florent Saint-Elair Tel: (415) 541-9980 Fax: (510) 276-2648
1.2 Official Correspondent
Gary J. Allsebrook, Consultant Requlatory Management Services 16303 Panoramic Wav San Leandro CA USA 94578-1116 Tel/fax: (510) 276-2648 Cell: (510) 388-5001 Email: regman10@comcast.net
1.3 Date of Submission
November 28, 2006
1.4 Device Name
Classification Name: Common/Usual Name: Proprietary Name:
PACS Soft-copy reading and acquisition system Advanced 3D Web PACS TM
1.5 Substantial Equivalence
Advanced 3D Web PACS™ has indications for use and a target population similar to other medical image management devices, including Acculmage, AccuView, (K990241), Neo Imagery Technologies, Insight Diagnostic Imaging Workstation (K982535) and Picker, Voxel Q™ and Voyager™ (K962010). All of
DEC 1 2 2006
1
the functions that Advanced 3D Web PACS™ performs are available in at least one of the listed substantially equivalent devices. In most cases, the function is available in all of them. There are no significant differences between Advanced 3D Web PACS™ and the collective functions of all the predicate devices.
1.6 Device Description and Intended Use
Advanced 3D Web PACS™ is a PACS system, comprised of acquisition components (Medweb secure DICOM Proxy Web Server, ), a central system manager component (Medical Transcription Server), a diagnostic workstation component (Radiologist Dashboard©), and an archiving component (DICOM Archive). The data flow is such that patient and procedure information 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 searches for and retrieves relevant prior 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 work list. The image data is transmitted to and rendered on 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 Advanced 3D Web PACS™ central system manager registers a report, 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.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA
Advanced 3D Web 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. Advanced 3D Web 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.
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1.7 Software Development
Nexsys Electronics, Inc, dba Medweb LLC certifies that the Advanced 3D Web software is designed, developed, tested and validated according to PACS TM written procedures. These procedures identify individuals within the organization
responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. The software developed for this product is used to provide diagnostic quality images and associated information for the intended users.
1.8 Safety and Effectiveness
General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and any warnings or cautions to provide 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. . Advanced 3D Web PACS™ is a software application(s) device. 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 Advanced 3D Web PACS™ device, which would be used in conjunction with the Advanced 3D Web 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 Advanced 3D Web PACS™ device is "minor".
Substantial Equivalence Summary:
Advanced 3D Web PACS™ is substantially equivalent in design and intended use(s) to diagnostic workstations, PACS and image management systems and substantiated in the substantial equivalence comparison chart in Tab 8. Any differences between the Advanced 3D Web PACS™ and the predicate devices have no significant influence on safety and effectiveness. Advanced 3D Web PACS™ , therefore, raises no new issues of safety or effectiveness from the predicate devices.
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Image /page/3/Picture/0 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" and is arranged around the top and left side of the circle. The graphic in the center consists of three curved lines that appear to be stylized representations of a human figure.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Nexsys Electronics, Inc. dba Medweb LLC % Mr. Gary J. Allsebrook Consultant Regulatory Management Services 16303 Panoramic Way SAN LEANDRO CA 94578-1116
DEC 1 2 2006
Re: K063221
Trade/Device Name: Nexsys, dba Medweb, LLC Advanced 3D Web PACS™ Picture Archiving and Communications System
Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 20, 2006 Received: October 24, 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/11 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. There are four stars below the word "Centennial". The logo appears to be a commemorative emblem for the centennial anniversary of the FDA.
Protecting and Promoting Public Health
4
Page 2 --
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast of advised that I between that your device complies with other requirements of the Act that I DIT has made a and regulations administered by other Federal agencies. You must or any I cactar surates and regularents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT at 607), laocing (21 OF X 1 a 1 2 1 2 3 1 2 3 1 2 1 and if applicable, the electronic fordiner and quality byevisions (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) I his icher will and in you w ought in the FDA finding of substantial equivalence of your device to a legally premaired predicated. "The 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 If you desire specific do ne 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 (21GF KT art 607.77). "100 may of Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
on at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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): K063221
Nexsys, dba Medweb, LLC, Advanced 3D Web PACS™ Device Name: Picture Archiving and Communications System
Indications For Use:
Advanced 3D Web PACS™ is a PACS and teleradiology system used to receive DICOM and other medical 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. Advanced 3D Web 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,
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammodraphic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA
(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)
ાર
Over-the-Counter Use
David R. Ingram
(Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________