(91 days)
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No
The summary describes a standard PACS system for image management and distribution, with no mention of AI or ML capabilities.
No.
The device is a PACS system for managing and distributing medical images, not for therapy.
No
The text states that lossy compressed mammographic images are not intended for diagnostic review, and the system is primarily for managing, archiving, and displaying images rather than interpreting them for diagnosis.
Yes
The device is described solely as "web-based distributed software" and its functions are related to managing, manipulating, displaying, and distributing medical images and information. There is no mention of any accompanying hardware component that is part of the device itself.
Based on the provided information, ExaPACS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- ExaPACS Function: ExaPACS is a software system that manages, archives, retrieves, and displays medical images (like CT, MR, and CR scans). It facilitates the distribution of these images and related information within a PACS environment.
- No Specimen Analysis: The description of ExaPACS does not mention any analysis of biological specimens. Its function is centered around the handling and display of images generated by imaging modalities.
Therefore, ExaPACS falls under the category of medical image management and display software, not an IVD.
N/A
Intended Use / Indications for Use
ExaPACS is a web-based distributed software that manages the archival, retrieval, and distribution of medical images and relevant information such as patient demographics and examination on an within the system and other DICOM-compliant imaging devices including CT scanners, MR imager, CR systems, and image viewing workstations among a Picture Archive Communication System (PACS) environment for specific purposes such as telecommunications, fast demonstration, tele-consultation, eic.
ExaPACS is intended for the manipulation, management, display of medical images, and to make that information, whether included textual reports or not, available across a network via web nart whan interfaces.
Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
Product codes
LLZ
Device Description
ExaPACS is a web-based distributed software that manages the archival, retrieval, and distribution of medical images and relevant information such as patient demographics and examination on an within the system and other DICOM-compliant imaging devices including CT scanners, MR imager, CR systems, and image viewing workstations among a Picture Archive Communication System (PACS) environment.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
DICOM-compliant imaging devices including CT scanners, MR imager, CR systems
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
FEB - 4 2010
Medincom Technology Corp. % Mr. Marc Mouser Underwriters Laboratories, Inc. Laboratory and Testing 2600 NW Lake Rd. CAMAS WA 98607-9526
Re: K093444
Trade/Device Name: ExaPACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 8, 2010 Received: January 19, 2010
Dear Ms. Mouser:
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 idencions 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 Amendmonts, 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish friuter announcements concerning your device in the Federal Register.
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 mauton coss not hour 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 liasting (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
and recentive storporation
Indications for Use
Applicant:
Medincom Technology Corporation
510(k) Number(if known):
Device Name:
ExaPACS
Indications for Use:
ExaPACS is a web-based distributed software that manages the archival, retrieval, and distribution of medical images and relevant information such as patient demographics and examination on an within the system and other DICOM-compliant imaging devices including CT scanners, MR imager, CR systems, and image viewing workstations among a Picture Archive Communication System (PACS) environment for specific purposes such as telecommunications, fast demonstration, tele-consultation, eic.
ExaPACS is intended for the manipulation, management, display of medical images, and to make that information, whether included textual reports or not, available across a network via web nart whan interfaces.
Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ NO (21 CFR 801 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE on another Page if needed)
Concurrence of CRH, Office of Service Evaluation, BUDGET
OIUP
(Division Sign-Off)
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Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number
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