(22 days)
Not Found
No
The description focuses on the hardware and basic image processing capabilities of a CR system, with no mention of AI or ML terms or functionalities. The performance study describes an evaluation of a grid suppression feature, which is a standard image processing technique, not indicative of AI/ML.
No
This device is a diagnostic imaging system that reads latent images from phosphor plates and produces digital images for projection radiography; it is not described as providing any therapeutic treatment.
No
The device itself is a scanner that produces digital images for projection radiography. While the output images may be used for diagnostic purposes, the device's function as described is image acquisition and processing, not diagnosis. The "Summary of Performance Studies" indicates the images can be used for diagnostic image quality, but the device description does not mention any diagnostic capabilities of the device itself.
No
The device description explicitly lists hardware components such as a storage phosphor reader, CR cassette, HeNe laser, and an internal imaging plate eraser, indicating it is a hardware system with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "producing a digital image for projection radiography applications." This refers to medical imaging of the human body, not testing of samples taken from the body (which is the core of IVD).
- Device Description: The description details a system for reading imaging plates used in radiography, processing the image, and preparing the plate for reuse. This aligns with medical imaging equipment, not IVD devices.
- Input Imaging Modality: "Storage phosphor imaging plate" is a modality used in medical imaging, not for analyzing biological samples.
- Performance Studies: The performance study focuses on the impact of image processing (grid suppression) on the diagnostic quality of radiographic images, as assessed by radiologists. This is relevant to medical imaging interpretation, not IVD testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such functions.
N/A
Intended Use / Indications for Use
The KODAK DirectView CR 800 System and the KODAK DirectView CR 900 System are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiology applications.
Product codes
MOB
Device Description
The KODAK DirectView CR 800 is a single cassette computed radiography (CR) system while the KODAK DirectView CR 900 is an autoloading CR system. Each CR system contains a storage phosphor reader, CR cassette, HeNe laser, QA workstation with image processing software, and a DICOM network connection. These CR systems are capable of reading the latent image formed on a storage phosphor imaging plate in a CR cassette and producing a digital image. The system scans the phosphor plate, communicates the image data to a host (e.g. soft copy review workstation or laser printer) and erases the residual image on the plate. An internal imaging plate eraser removes the residual image. The plate is then returned to the cassette, ready for the next exposure.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Radiography (CR)
Anatomical Site
Not Found
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
An evaluation was performed, with hard copy CR images, to study the impact of grid suppression on diagnostic image quality. The effect of grid suppression on images with and without grids was assessed across several grid frequencies, orientations and a variety of radiographic exams (e.g. chest, abdomen, spine, shoulder, pelvis).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An evaluation was performed, with hard copy CR images, to study the impact of grid suppression on diagnostic image quality. The effect of grid suppression on images with and without grids was assessed across several grid frequencies, orientations and a variety of radiographic exams (e.g. chest, abdomen, spine, shoulder, pelvis). On a scale of 1 to 9 with 7 being acceptable for interpretation, ten radiologists rated the exams as acceptable for interpretation or better when grid suppression was applied. Average scores ranged from 7.2 with no grid suppression to 7.7 with maximum grid suppression applied. The differences in rating for with and without grid suppression were not clinically significant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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MAR 2 1 2002
510(k) Summarv
1. Company Identification
Eastman Kodak Company 343 State Street Rochester, NY 14650
Establishment Registration: 1317267
2. Contact Person
Susan Pate Regulatory Affairs Associate (716)-781-6314
3. 510(k) Summary Preparation Date
2/26/2002
4. Device Name
Trade Name: KODAK Direct View CR 800 System KODAK DirectView CR 900 System
Common Name: Storage phosphor reader with software modification
5. Device Classification
Class II
6. Indications for Use
The KODAK DirectView CR 800 System and the KODAK DirectView CR 900 System are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiology applications.
7. Description of Device
The KODAK DirectView CR 800 is a single cassette computed radiography (CR) system while the KODAK DirectView CR 900 is an autoloading CR system. Each CR system contains a storage phosphor reader, CR cassette, HeNe laser, QA workstation with image processing software, and a DICOM network connection.
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These CR systems are capable of reading the latent image formed on a storage phosphor imaging plate in a CR cassette and producing a digital image. The system scans the phosphor plate, communicates the image data to a host (e.g. soft copy review workstation or laser printer) and erases the residual image on the plate. An internal imaging plate eraser removes the residual image. The plate is then returned to the cassette, ready for the next exposure.
Software Modification
Anti-scatter grids are commonly used in radiography to reduce scattered x-rays and improve image contrast and signal-to-noise ratio. The new software modification uses a grid detection and suppression algorithm to reduce line artifacts caused by the use of anti-scatter grids. These grid artifacts, when present, can be distracting to radiologists when reviewing CR images, particularly in soft copy. The user may select the amount of grid suppression to be applied within a range of 0-15 through preference settings at the operator console of the CR system.
All other features and capabilities of the CR 800 and the CR 900 system remain unchanged by this software modification.
8. Substantial Equivalence
The analytical characteristics of the grid detection and suppression algorithm were evaluated for a wide variety of grids commonly in use in the medical community. The algorithm was effective at reducing grid induced artifacts.
An evaluation was performed, with hard copy CR images, to study the impact of grid suppression on diagnostic image quality. The effect of grid suppression on images with and without grids was assessed across several grid frequencies, orientations and a variety of radiographic exams (e.g. chest, abdomen, spine, shoulder, pelvis). On a scale of 1 to 9 with 7 being acceptable for interpretation, ten radiologists rated the exams as acceptable for interpretation or better when grid suppression was applied. Average scores ranged from 7.2 with no grid suppression to 7.7 with maximum grid suppression applied. The differences in rating for with and without grid suppression were not clinically significant.
The KODAK DirectView CR 800 and KODAK DirectView CR 900 with grid suppression are substantially equivalent to the previously cleared device [K923544].
KODAK DirectView CR 800 and CR 900 Systems 510(k) Submission
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is in a bold, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Susan Pate Regulatory Affairs Associate Eastman Kodak Company 343 State Street ROCHESTER NY 14650
AUG 23 2013
Re: K020635
Trade/Device Name: Kodak DirectView CR 800 and CR 900 Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: February 26, 2002 Received: February 27, 2002
Dear Ms. Pate:
This letter corrects our substantially equivalent letter of March 21, 2002.
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 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 (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 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,
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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Attachment 9 - Indications for Use
K020635 510(k) Number (if known): 幽绘丝
Device Name: KODAK DirectView CR 800 and KODAK DirectView CR 900 Systems
Indications of Use: The KODAK DirectView CR 800 System and the KODAK Direct View CR 900 System are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiography applications.
Concurrence of CDRH, Office of Device Evaluation
Prescription Use_ (Per 21 CFR 801.109) OR
Over-The-Counter
David A. Segerson
KODAK DirectView CR 800 and CR 900 Systems 510(k) Submission