(83 days)
The KODAK Digital Science Medical Image Manager is an extension of the KODAK Health Sciences Imagelink System with the intended use to be used as a network gateway to a host of image management and printing devices.
The KODAK Digital Science Medical Image Manager will provide network access for both point -to - point and network capable image and information sources. The Image Manager will provide a value added service to point - to - point devices by adding services including routing to multiple destinations and access to multiple printers. However, evaluation of soft copy or hard copy output provides adequate opportunity for competent human intervention. PACS are not represented to be used in supporting or sustaining human life, nor do they represent a potential for unreasonable risk of illness or injury.
The general hardware configuration of the KODAK digital Science Medical Imager contains the following major components:
-Power Supply
-Main System Circuit Board
-Hard Dick
-Internal Removable Media
-Keypad
Optional Accessories:
-Keypad Accessories
-Mini-keypad
-Microphone
-Modality Store Connection
-Keyboard
-Bar Code Reader
-Magnetic Stripe Reader
This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The provided text is a 510(k) premarket notification for the KODAK Digital Science Medical Image Manager, focusing on its general information, intended use, and a comparison of its features with a previous Kodak product. It details hardware components, power requirements, environmental conditions, acquisition unit specifications (disk storage, network capability, video/digital inputs, capture/store times), and reader unit specifications (inputs, outputs, image presentation options).
Therefore, I cannot provide the requested information.
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KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGE Premarket Notification: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
INTRODUCTION I.
The KODAK Digital Science Medical Image Manager is an extension of the KODAK Health Sciences Imagelink System with the intended use to be used as a network gateway to a host of image management and printing devices.
GENERAL INFORMATION II.
APR 1 7 1996
Name of Manufacture: Eastman Kodak Company Health Sciences Division 18325 Waterview Parkway Dallas, Texas 75252-8026
Establishment Registration Number:
Device Name:
KODAK Digital Science Medical Image Manager
Device Classification:
Class I Device
III. THE DEVICE
The general hardware configuration of the KODAK digital Science Medical Imager contains the following major components:
-Power Supply -Main System Circuit Board -Hard Dick -Internal Removable Media -Keypad
Optional Accessories: -Keypad Accessories -Mini-keypad -Microphone -Modality Store Connection -Keyboard -Bar Code Reader -Magnetic Stripe Reader
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KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGE Premarket Notification: 510(k) IV. INDICATIONS FOR USE
The KODAK Digital Science Medical Image Manager will provide network access for both point -to - point and network capable image and information sources. The Image Manager will provide a value added service to point - to - point devices by adding services including routing to multiple destinations and access to multiple printers. However, evaluation of soft copy or hard copy output provides adequate opportunity for competent human intervention. PACS are not represented to be used in supporting or sustaining human life, nor do they represent a potential for unreasonable risk of illness or injury.
V. COMPARISON OF FEATURES
| KODAK EKTASCAN | KODAK DIGITAL |
|---|---|
| IMAGELINK | SCIENCE |
| Ultrasound System | Remote Network Interface |
General
| General | ||
|---|---|---|
| K-Number | K-931551 | This 510(k) |
| PowerRequirements | 90-132VAC/47-63Hz180-264VAC/47-63Hz | 100VAC +/-10%,50/60 Hz (+/-2%)250w120VAC +/-10%,60Hz (+/-2%)250w220VAC +/-10%,50/60 Hz (+/-2%)250w240VAC +/-10%,50/60 Hz (+/-2%)250w |
| Environmental | 15-35 degrees C / 15-90% RHnon-condensing | 41-95 degrees F / 15-80% RHnon-condensing |
Acquisition Unit
| Removable Disk | 2.5" Hard Disk | 3.5" Floppy, 3.5" Magneto Optical (MOD) |
|---|---|---|
| Disk Storage Capacity | 30,40,60,80,105 Mbytes | 1-4 GBytes |
| Network Capability | Ethernet | Ethernet |
| Video Image Inputs | Monochrome:RS-170/CCIRRed,Green,Blue (RGB) | Monochrome:RS-170/CCIRRed,Green,Blue (RGB),CINE Loop, Motion Video |
| Digital Image Inputs | None | 8 and 12 Bit Digital Images in UBMED Format |
| Serial Control Inputs | None | RS-232, RS-422 |
| Image Capture Time | 1/30 second (.25MB) | Grayscale Video: .2s (1MB)Color Video: .25s(1MB)8-Bit Digital: .2s (1MB) |
| Image Store Time | Grayscale Video: <2 seconds (.25MB)Color Video: <5 seconds (.75MB) | Grayscale Video: .5s (1MB)Color Video: 1.5s (3MB)8-Bit Digital: 5s (1MB) |
Reader Unit
| Inputs | Removable Disk CartridgeEthernet - ACR/NEMA Format | 3.5" Floppy, 3.5" Magneto OpticalEthernet - DICOM Format, HIS/RIS Interface |
|---|---|---|
| Outputs | SCSI, Video, RS-485, RS-422, RS-232 | Ethernet, RS-485, High Speed Optical, Modem,ATM, SCSI |
| Image Presentation | 1,2,4,6,8,9,12,15,16,20,24,30,35 | 1,2,4,6,8,9,12,15,16,20,24,30,35.slide |
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.