(9 days)
Not Found
No
The document describes standard image processing algorithms (JPEG, wavelet) and a PACS viewing system, with no mention of AI or ML technologies.
No
The device is described as software for viewing, organizing, and displaying patient images for reference and referral, not for directly treating a condition or disease.
No
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state multiple times that the device is not intended for diagnosis, e.g., "When used for mammography the WEB1000 should never be used as a diagnostic tool" and "It is not for the purposes of diagnosis."
Yes
The device is described as a "software package" that "may be marketed as a software only solution". While it can be used "in conjunction with standard PC hardware", the description explicitly states that the "network hardware used to support the TCP/IP stack is superfluous to WEB1000™", indicating the core medical device functionality resides solely in the software.
Based on the provided text, the AGFA WEB1000 software is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- WEB1000's Intended Use: The intended use of the WEB1000 is clearly stated as "viewing, assembling, organizing, sharing, and displaying patient images and demographic information." It explicitly states it is for "reviewing and referral image data" and "reference viewing of medical data."
- Exclusion of Diagnostic Use: The document repeatedly emphasizes that the WEB1000 is not intended for diagnostic use, particularly for mammography images.
- No Specimen Analysis: The device description focuses on handling and displaying medical images (DICOM images) from various modalities, not on analyzing biological specimens.
Therefore, the AGFA WEB1000 software falls under the category of medical image management and viewing software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The WEB1000™ software and the computer platform constitute a system for viewing of medical image data by trained and qualified professionals. The system is intended for use in the assembly, organization, sharing, and display of patient images and demographic information for review and referral purposes only. The WEB1000™ applet can be used for viewing images over a hospital intranet or over the Internet from a remote location. Images stored on WEB1000™ are transient, as WEB1000™ is not intended to be an archiving device.
AGFA's WEB1000 software is intended for installation on standard hardware exceeding minimum specifications. The system is intended for viewing, assembling, organizing, sharing, and displaying patient images and demographic information. Images on the WEB1000 can be part of your evolving imaging workflow. It can also be used remotely over a hospital intranet or over the Internet.
When used by trained and qualified professionals the WEB1000 may be used for reviewing and referral image data collected from various imaging modalities including mammography. When used for mammography the WEB1000 should never be used as a diagnostic tool.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
WEB1000™ is a software package, which may be marketed as a software only solution, as well was in conjunction with standard PC hardware. WEB1000™ is a PC-based, DICOM-compliant PACS device that is able to receive and display DICOM images. Images sent to WEB1000™ are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by WEB1000™ to create JPEG and wavelet images follow known and accepted protocols.
Images sent to WEB1000™ can be viewed using a Java applet that runs within a web browser such as Netscape or Internet Explorer. The WEB1000™ applet can be used for the purposes of viewing images over a hospital intranet, or over the Internet from a remote location. Images stored on WEB1000™ are transient, as WEB1000™ is not intended to be an archiving device. WEB1000™ uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to WEB1000™. WEB1000™ is intended for reference viewing of medical data. It is not for the purposes of diagnosis. Images viewed from WEB1000™ are used from reference purposes only. Diagnostic reports created from diagnostic viewing application and distributed through WEB1000™ can be used for treatment of a patient.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Various imaging modalities including mammography.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained and qualified professionals, hospital intranet or over the Internet from a remote location.
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
DEC 2 2 2005
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitted by: Agfa Corporation 10 South Academy St. Greenville, SC 29602-9048
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- Date Prepared September 14, 2005
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- Contact Person Phil Cuscuna Phone: (519) 572-9339 FAX: (519) 746-3745
3. Device Name and Classification
Trade Name: WEB1000 ™ Picture archiving and communications Classification Name: system. Classification Panel: Radiology 21 CFR § 892.2050 CFR Section: Device Class: Class II Device Code: LLZ
4. Intended Use
The WEB1000™ software and the computer platform constitute a system for viewing of medical image data by trained and qualified professionals. The system is intended for use in the assembly, organization, sharing, and display of patient images and demographic information for review and referral purposes only. The WEB1000™ applet can be used for viewing images over a hospital intranet or over the Internet from a remote location. Images stored on WEB1000™ are transient, as WEB1000™ is not intended to be an archiving device.
5. Substantial Equivalence
The predicate device is General Electric Medical Systems' Centricity™ PACS System (Web Client Component) - a Class II device (FDA's Clearance number: K043415; FDA's clearance date: January 21, 2005)
6. Device Description
WEB1000™ is a software package, which may be marketed as a software only solution, as well was in conjunction with standard PC hardware. WEB1000™ is a PC-based, DICOM-compliant PACS device that is able to receive and display DICOM images. Images sent to WEB1000™ are converted into formats suitable
1
for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by WEB1000™ to create JPEG and wavelet images follow known and accepted protocols.
Images sent to WEB1000™ can be viewed using a Java applet that runs within a web browser such as Netscape or Internet Explorer. The WEB1000™ applet can be used for the purposes of viewing images over a hospital intranet, or over the Internet from a remote location. Images stored on WEB1000™ are transient, as WEB1000™ is not intended to be an archiving device. WEB1000™ uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to WEB1000™ . WEB1000™ is intended for reference viewing of medical data. It is not for the purposes of diagnosis. Images viewed from WEB1000™ are used from reference purposes only. Diagnostic reports created from diagnostic viewing application and distributed through WEB1000™ can be used for treatment of a patient.
7. Comparison of Technological Differences:
Technological and functional characteristics of the Agfa's WEB1000™ software are identical to those of General Electric Medical Systems' Centricity™ PACS System (Web Client Component). Both of these display stations allow for the ability to display images from a number of modalities including MG (Digital Mammography) class images for nondiagnostic purposes.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission of promoting health, well-being, and human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 2005
AGFA Corporation % Mr. Jeffrey D. Rongero Senior Project Engineer Conformity Assessment Services Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709 Re: K053458 Trade/Device Name: WEB1000 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 7, 2005 Received: December 13, 2005
Dear Mr. Rongero:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leviewed your becalent by equivalent (for the indications for use stated in above and nave acterim.rearketed predicate devices marketed in interstate commerce prior to the cherolors to regary mantonto of the Medical Device Amendments, or to devices that have been May 20, 1770, the chance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmed in accordal of a premarket approval application (PMA). You may, therefore, market the do not require approval of a provisions of the Act. The general controls provisions of the Act ut vice, subject to the general estimon, 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 If your de rice is classified (500 acch additional controls. Existing major regulations affecting your Apployal), It they of July of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA de view of to total a nouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I rease be advised that i 22 the made complies with other requirements of the Act or any Fort has made a acterininations administered by other Federal agencies. You must comply with all the r cacraf statues and regulation but not limited to registration and listing (21 CFR Part 807): labeling Act srequirements moranmantacturing practice requirements as set forth in the quality systems (QS) (= C+1 e r (2 ) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manies of substantial equivalence of your device to a legally premarked nothleadon: "The PDF mining if and in the 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 acriee for your as 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" (21 CFR Also, production other general information on your responsibilities under the Act from the 807.77). Tou may obtain onto general and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html
Sincerely yours,
Nancy C. Hugdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Kos 3458 510(k) Number (if known):
Device Name:_WEB1000
Indications For Use:
AGFA's WEB1000 software is intended for installation on standard hardware AGT A $ WED 1000 ookmailmum specifications. The system is intended for fileeting of Cxocoding minimand, sharing, and displaying patient images and viewing, assombling, organisms on the WEB1000 can be part of your evolving demographic information in also be used remotely over a hospital intranet or over the Internet.
When used by trained and qualified professionals the WEB1000 may be used for vincen used by trains and referral image data collected from various reviewing and rolling mammography. When used for mammography the WEB1000 should never be used as a diagnostic tool.
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)
David h. hlynn
(Division Sicn-Off) Division of Reproductive, and Padiological Devices 510(k) Number _