(16 days)
Not Found
Not Found
No
The provided 510(k) summary does not mention AI, ML, deep learning, or any related terms, and the device description is not available to provide further clues.
No
The device is described as a "diagnostic x-ray system" used for "examination," indicating its purpose is to identify or diagnose conditions, not to treat them.
Yes
The "Intended Use / Indications for Use" states it is a "diagnostic x-ray system for generation of x-rays for examination of various anatomical regions."
No
The intended use describes a "permanently installed diagnostic x-ray system," which is a hardware device. The summary does not mention any software-only components or functions.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "diagnostic x-ray system for generation of x-rays for examination of various anatomical regions." This describes a device that produces images of the body using radiation, which is an in vivo diagnostic method (examining the body directly).
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform such tests.
The information provided confirms it's an imaging system, not a laboratory test device.
N/A
Intended Use / Indications for Use
The KODAK DirectView DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Product codes
KPR, MQB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-rays
Anatomical Site
various anatomical regions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo includes the department's name in blue, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written in a clear, sans-serif font. To the left of the text is a stylized symbol, also in blue, which is part of the department's official branding.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Christine E. Ehmann Manager, Regulatory Affairs Eastman Kodak Company 343 State Street ROCHESTER NY 14650
AUG 2 0 2013
Re: K051258
Trade/Device Name: Kodak Direct View DR 7500 System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MQB Dated: May 13, 2005 Received: May 18. 2005
Dear Ms. Ehmann:
This letter corrects our substantially equivalent letter of June 1, 2005.
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 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 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 Parts 801 and 809); medical device reporting (reporting of
1
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) 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 nredicate 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,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Kodak DirectView DR 7500 System
ATTACHMENT I 510(k): Eastman Kodak Company
Statement of Intended Use
510(k) Number (if known): KOS1258
Device Name: Kodak DirectView DR 7500 System
Intended Use and Indications for Use:
The KODAK DirectView DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
Concurrence of CDRH, Office of Device Evaluation
\
Prescription Use (per 21 CFR 801.109) OR
Over-the counter use
Rata Pease
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K051258