(106 days)
No
The description focuses on digitizing and transmitting X-ray films using standard protocols (DICOM) and does not mention any AI/ML capabilities for image analysis or processing.
No
The device converts X-ray films into digital images for display, transmission, and archiving within a PACS. It does not directly provide therapy or affect the structure or function of the body.
No
The device digitizes X-ray films for transmission and archiving within a PACS system. It does not perform any diagnostic analysis or interpretation on the images.
No
The device description explicitly states it is a "system designed to convert X-ray films into digital images," implying the presence of hardware components (a digitizer) to perform this conversion.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to digitize X-ray films for electronic transmission, archiving, and quicker consultations. This is related to medical imaging and data management, not the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces that the device converts X-ray films into digital images for display, transmission, and archiving. This aligns with medical imaging workflows, not IVD testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or treatment based on specimen analysis
The device's function is to handle and manage existing medical images (X-ray films), not to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The KDS FD is designed to allow operators and physicians greater access to images by transmitting them electronically over networks instead of physically sending films. The system allows for much quicker consultations with experts in distant facilities. Also, archiving electronically for faster image recall and assembly of historical studies can be accomplished with ease. The KDS FD is a DICOM conformant digitization product designed for use within a Picture Archiving and Communication System (PACS).
Product codes
Not Found
Device Description
Kodak's Film Digitizer (KODAK DIGITAL SCIENCE Film Digitizer or KDS FD) is a system designed to convert X-ray films into digital images for display, transmission, and/or archiving. The KDS FD is designed to accomplish its interface over the American College of Radiology-National Electrical Manufacturers Association (ACR-NEMA) standard known as DICOM (Digital Imaging and Communications in Medicine) which gives direct access to imaging devices, Local Area Networks (LANs), and Wide Area Networks (WANs).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray films
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operators and physicians / 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENE
I. DATE PREPARED: May 3, 1996
SUBMITTER: II.
Eastman Kodak Company Health Imaging Division 18325 Waterview Parkway Dallas, Texas 75252-8026
CONTACT PERSON: III.
Edward A. Weaver Regulatory Affairs (214) 454-1506
IV DEVICE NAME:
| Trade Name | KODAK Digital Science Film Digitizer L7501
KODAK Digital Science Film Digitizer L7506 (with Film Autofeeder) |
|-------------|-----------------------------------------------------------------------------------------------------------------|
| Common Name | Picture Archiving and Communications Systems (PACS) Component |
V DEVICE CLASSIFICATION
FDA has classified the predicate device as Regulatory Class II under 21 CFR 892.1750.
VI. PREDICATE DEVICE:
KODAK Film Digitizer ("FD')
VII. DESCRIPTION OF DEVICE:
Kodak's Film Digitizer (KODAK DIGITAL SCIENCE Film Digitizer or KDS FD) is a system designed to convert X-ray films into digital images for display, transmission, and/or archiving. The KDS FD is designed to accomplish its interface over the American College of Radiology-National Electrical Manufacturers Association (ACR-NEMA) standard known as DICOM (Digital Imaging and Communications in Medicine) which gives direct access to imaging devices, Local Area Networks (LANs), and Wide Area Networks (WANs).
1
VIII. INDICATIONS FOR USE:
The KDS FD is designed to allow operators and physicians greater access to images by transmitting them electronically over networks instead of physically sending films. The system allows for much quicker consultations with experts in distant facilities. Also, archiving electronically for faster image recall and assembly of historical studies can be accomplished with ease. The KDS FD is a DICOM conformant digitization product designed for use within a Picture Archiving and Communication System (PACS).
IX. Substantial Equivalence
The purpose and functionality of the KDS FD is substantially similar to the Vortech (Kodak) FD system (K915362, November 27, 1991), as well as numerous other x-ray digitizers currently on the market. The basis for the equivalence is that both systems consist of a Lumisys laser film digitizer with image preview software with similar functionality.
Each system performs high definition scanning of images on film for display on monitors. The level of clarity and definition is similar. The ability to input and tie in patient information to complete records is similar -- the FD allowed for manual data entry only whereas the KDS FD allows for manual data entry or an interface into a HIS/RIS to capture patient demographic data.
The transmission of the images across networks is also supported by both systems. Kodak used ACR-NEMA 2.0 for the FD and will use DICOM for the KDS FD. The function of image routing is supported by both systems.
The only real difference in the systems is the choice of hardware. Both systems use reliable, mature components. The software and system functionalities are comparable with few minor exceptions in patient information fields and networking options.
Based on the similarity of the purpose and functionalities of these two systems. Kodak concludes that the KODAK DIGITAL SCIENCE Film Digitizer is substantially equivalent to the Kodak Film Digitizer.