(195 days)
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No
The document describes a standard image management system for PACS, focusing on acquisition, printing, review, archive, and communication. There is no mention of AI, ML, or any related concepts in the intended use, device description, or specific sections for AI/ML information. The emphasis on "competent human intervention" further suggests a traditional system.
No
The device is described as a system for image acquisition, printing, review, archiving, retrieval, and communication of diagnostic image information within a PACS, which indicates it is an imaging management system, not a therapeutic device.
No
The device is described as an "image management system" for "image acquisition, printing, review, archive/retrieval, and communications" of "diagnostic image information." It facilitates the handling of diagnostic images but does not actively perform a diagnostic function itself.
No
The device description explicitly states it is composed of two major components, the KODAK Digital Science Medical Modality Acquisition Unit and the KODAK Digital Science Medical Printer Interface Unit, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a DICOM conformant product designed for use within a PACS for managing diagnostic image information. This is related to medical imaging, not the examination of specimens from the human body.
- Device Description: The description focuses on components for image acquisition, printing, review, archive/retrieval, and communications within an image management system. This aligns with medical imaging workflows.
- Input Imaging Modality: The listed modalities (C-Arm, Digital Subtraction Angiography, Nuclear Medicine, Ultrasound, and other video modalities) are all medical imaging techniques.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is centered around the management and display of medical images.
N/A
Intended Use / Indications for Use
The KODAK Ektascan Imagelink System (KEIS) is a DICOM conferment product designed for use within a Picture Archiving and Communication System (PACS).
Product codes
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Device Description
The KODAK Ektascan Imagelink System [KEIS] is composed of components common to all image management systems for image acquisition, printing, review, archive/retrieval, and communications. These components can be combined into customized solutions for the management of diagnostic image information.. Evaluation of soft and or hard copy output provides adequate opportunity for competent human intervention.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
C-Arm, Digital Subtraction Angiography, Nuclear Medicine, Ultrasound, and other video modalities.
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
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
NOV 1 4 199
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
- I. DATE PREPARED: April 30, 1996 Revised: November 11, 1996
- II. SUBMITTER:
Eastman Kodak Company Health Imaging Division 18325 Waterview Parkway Dallas, Texas 75252-8026
-
CONTACT PERSON: III.
Nancy Butcher Regulatory Affairs (214) 454-1417 -
IV DEVICE NAME:
KODAK Digital Science Medical Printer Interface Unit (K961740) Trade Name
Picture Archiving and Communications Systems (PACS) Components Common Name
-
V DEVICE CLASSIFICATION
FDA has classified the predicate device as Regulatory Class II under 21 CFR 892.1750. -
VI. PREDICATE DEVICE:
KODAK Ektascan Imagelink System
VII. DESCRIPTION OF DEVICE:
The KODAK Ektascan Imagelink System [KEIS] is composed of components common to all image management systems for image acquisition, printing, review, archive/retrieval, and communications. These components can be combined into customized solutions for the management of diagnostic image information.. Evaluation of soft and or hard copy output provides adequate opportunity for competent human intervention.
1
INDICATIONS FOR USE: VIII.
The KODAK Ektascan Imagelink System (KEIS) is a DICOM conferment product designed for use within a Picture Archiving and Communication System (PACS).
The KODAK Ektascan Imagelink System is composed of two major components, the KODAK Digital Science Medical Modality Acquisition Unit and the KODAK Digital Science Medical Printer Interface Unit. These systems can exit together or independently on a network.
V. COMPARISON OF FEATURES:
| Characteristics | KODAK Digital Science
Medical Modality
Acquisition Unit and
Printer Interface Unit | KODAK Ektascan
Imagelink System |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Knumber | this submission | K931551 |
| GENERAL | | |
| Advertised use | Productivity improvement,
eliminate film cassettes and
darkroom processing, eliminate
need to sterilize film cassettes | Productivity improvement,
eliminate film cassettes and
darkroom processing, eliminate
need to sterilize film cassettes |
| Input modalities
advertised | C-Arm, Digital Subtraction
Angiography, Nuclear Medicine,
Ultrasound, and other video
modalities. | C-Arm, Digital Subtraction
Angiography, Nuclear
Medicine, and Ultrasound |
| Power requirements | 90-132vac/47-63Hz
180-264vac/47-63Hz | 90-132vac/47-63Hz
180-264vac/47-63Hz |
| Environmental | 4-45 degrees C/15-90% RH
non-condensing | 4-45 degrees C/15-90% RH
non-condensing |
| Acquisition Unit | | |
| Removable Disk | 2.5" Hard Drive | 2.5" Hard Drive |
| Disk Storage Capacity | 105, 30, 60, 80 Mbytes | 30, 60 Mbytes |
| Network Capability | Ethernet | Ethernet |
| Video Inputs | Monochrome: RS-170/CCIR;
Red, Green, Blue (RGB) | Monochrome: RS-170/CCIR;
Red, Green, Blue (RGB) |
| Image Capture Time | 1/30 second | 1/30 second |
| Image Store Time | Less than I second | Less than 1 Second |
| Printer Interface Unit | | |
| Inputs | Removable Disk Cartridge,
Ethernet, DICOM v3.0 format
(ACR_NEMA) | Removable Disk Cartridge,
Ethernet, DICOM v3.0 format
(ACR_NEMA) |
| Outputs | SCSI, Video, RS-485, RS-422,
RS-232 | SCSI, Video, RS-485, RS-
422, RS-232 |
| Image Presentation | 1,2,4,6,8,9,12,15,16,24,35
images per frame, plus slides | 1,2,4,6,8,9,12,15,16,24,35
images per frame, plus slides |