(33 days)
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Not Found
No
The summary describes a standard PACS system for image management and distribution, with no mention of AI, ML, or advanced image processing features typically associated with AI/ML in medical imaging.
No
The device is described as an "image management system" for archiving, distributing, retrieving, and displaying images and data. Its function is to manage data, not to diagnose, treat, or prevent disease.
No
The device is described as an "image management system" that archives, distributes, retrieves, and displays images and data. Its function is to manage and present images, not to provide diagnostic analysis or interpretations of those images.
Unknown
The provided 510(k) summary does not contain a "Device Description" section, which is crucial for determining if the device is software-only. While it describes the function of the PACS system, it doesn't explicitly state whether it includes dedicated hardware components or is purely software running on existing infrastructure.
Based on the provided information, the KODAK CARESTREAM PACS is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for managing, archiving, distributing, retrieving, and displaying images and data from hospital modalities and information systems. This is related to medical imaging and information management, not the analysis of biological samples in vitro.
- Lack of IVD Characteristics: The description does not mention any activities typically associated with IVDs, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on in vitro analysis.
The KODAK CARESTREAM PACS is a medical image management system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The KODAK CARESTREAM 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
LLZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 4 2006
Ms. Carolyn L. Wagner Regulatory Affairs Specialist Health Group Eastman Kodak Company 343 State Street ROCHESTER NY 14650
Re: K053347
Trade/Device Name: Kodak Carestream PACS Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 2, 2005 Received: December 5, 2005
Dear Ms. Wagner:
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 (Premacket 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.
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.
1
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.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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
2
Kodak Carestream PACS
Statement of Intended Use
KOS3347 510(k) Number (if known):
Device Name: Kodak Carestrcam PACS
Intended Use and Indications for Use:
The KODAK CARESTREAM 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.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use (per 21 CFR 801.109)
OR
Over-the counter use
David de Legron
(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number