(79 days)
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No
The summary describes a standard PACS system for image management, archiving, and display. There is no mention of AI, ML, or any advanced image processing that would typically involve these technologies.
No
The device is an image management system used for archiving, distributing, retrieving, and displaying medical images and data, rather than directly treating or diagnosing a medical condition.
Yes
This device is described as an image management system with "primary diagnostic workstations" that archive/distribute/retrieve and display images and data from various hospital modalities, including those used for diagnosis (e.g., CT, MRI, Ultrasound, mammography). Its intended use to provide PACS solutions for hospitals supports its role in medical image review, which is a key component of diagnosis.
No
The device description explicitly states it integrates "proprietary and off the shelf (OTF) software integrated with OTF hardware components." This indicates it is not solely software.
Based on the provided information, the Kodak DirectView PACS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "image management" - archiving, distributing, retrieving, and displaying images and data from various medical imaging modalities. It does not mention analyzing biological samples or providing diagnostic information based on such analysis.
- Device Description: The description reinforces the image management function, focusing on handling images from modalities like CT, MRI, Ultrasound, etc. It doesn't describe any components or processes related to testing or analyzing biological specimens.
- Lack of IVD Characteristics: The information provided does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Reagents or assays
- Measurement of analytes
- Providing diagnostic information based on laboratory testing
The Kodak DirectView PACS is a Picture Archiving and Communication System (PACS), which is a type of medical device used for managing and displaying medical images. While these images are used by healthcare professionals for diagnosis, the PACS itself is not performing the in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Eastman Kodak DirectView PACS/Image Management System(DV PACS) intended use is to provide completely scaleable image/data management solutions for hospital and related institutions/sites including, at a minimum, local to wide area primary diagnostic workstations to enterprise storage centers. DV PACS also provides services that will allow remote sites to have access to diagnostic image/patient data through industry standard interfaces, including web browsers supported by Eastman Kodak and other's predicate devices. The Kodak DirectView PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive/ distribute/ retrieve and display images and data from all hospital modalities and information systems.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
DV PACS is designed using an open architecture that allows various proprietary and off the shelf (OTF) software integrated with OTF hardware components to be configured to meet the user's specific needs. Using DICOM and other industry standards, DirectView PACS archives/ distributes/retrieves and displays images and data from all hospital modalities including but not limited to, CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), mammography, cardio systems, digitized X-ray films, digital angiography, and fluoroscopy as well as all hospital/radiology information systems.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), mammography, cardio systems, digitized X-ray films, digital angiography, and fluoroscopy
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
hospital and related institutions/sites
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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).
0
MAY 2 9 2003
510(k) Summary 6.1
1. Company Identification
Eastman Kodak Company 343 State Street Rochester, NY 14650
2. Contact Person
Linda J. Moore, Dir.of Regulatory Affairs, HCIS Products Eastman Kodak Health Imaging 47315 Mission Falls Ct. Fremont, CA 94539 510-770-5456 Fax. 510-770-5544 Linda.j.moore@kodak.com
3. 510(k) Summary Preparation Date
March 7, 2003
4. Device Name
Kodak DirectView PACS/Image Management Systems
5. Device Classification
Class II
6. Intended Use/Device Description
Eastman Kodak DirectView PACS/Image Management System(DV PACS) intended use is to provide completely scaleable image/data management solutions for hospital and related institutions/sites including, at a minimum, local to wide area primary diagnostic workstations to enterprise storage centers. DV PACS also provides services that will allow remote sites to have access to diagnostic image/patient data through industry standard interfaces, including web browsers supported by Eastman Kodak and other's predicate devices. DV PACS is designed using an open architecture that allows various proprietary and off the shelf (OTF) software integrated with OTF hardware components to be configured to meet the user's specific needs. Using DICOM and other industry standards, DirectView PACS archives/ distributes/retrieves and displays images and data from all hospital modalities including but not limited to, CT, MRI, Ultrasound
1
(US), CR, DR, Nuclear Medicine (NM), mammography, cardio systems, digitized X-ray films, digital angiography, and fluoroscopy as well as all hospital/radiology information systems.
7. Substantial Equivalence Summary
The DirectView PACS/Image Management System is substantially equivalent in design and intended use to diagnostic radiological workstations, PACS and image management systems as substantiated in the feature comparison. The comparison listed in Section 3.3 clearly demonstrates that DirectView PACS/Image Management System is substantially equivalent in all areas such as functionality, user/software features, hardware components and connectivity. Although, the comparison only lists DirectView PACS equivalence to its predecessors. AccuRad and Archive Manager, the stated indications for use, listed on the comparison, does show substantial equivalence to other manufacturer's industry standard PACS/image management systems. Therefore, DirectView PACS raises no new issues of safety or effectiveness from its predicate devices.
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Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing right, stacked on top of each other. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 2003
Ms. Linda J. Moore Director, Regulatory Affairs, HCIS Products Eastman Kodak Company 47315 Mission Falls Ct. FREMONT CA 94539
Re: K030781
Trade/Device Name: Kodak DirectView PACS/Image Management System Regulation Number: 21 CFR $892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: March 7, 2003 Received: March 11, 2003
Dear Ms. Moore:
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 (PMA), it may be subject to 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.
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.
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This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
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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6.2 FDA Indications for Use
510K # K03078|
Device Name: Kodak DirectView PACS/Image Management System
The Kodak DirectView PACS is an image management system whose Indications for Use: intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive/ distribute/ retrieve and display images and data from all hospital modalities and information systems.
| Concurrence of CDRH, Office of Device Evaluation | |
|---|---|
| -- | -------------------------------------------------- |
Prescription Use (Per 21 CFR 801.109)
OR
Over - The - Counter _________________________________________________________________________________________________________________________________________________________
David R. Bergman