(83 days)
K-931551
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No
The document describes a network gateway for image management and printing, focusing on hardware components and basic routing functions. There is no mention of AI, ML, or any related concepts like image processing for analysis or interpretation.
No.
The device is described as an image manager that provides network access and routing for medical images, not for treating or diagnosing conditions.
No
The device is described as a network gateway for image management and printing devices, facilitating routing and access to printers. The description explicitly states that "evaluation of soft copy or hard copy output provides adequate opportunity for competent human intervention" and that PACS are not represented to be used "in supporting or sustaining human life." It acts as an image manager, not a tool for directly diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components, including a power supply, circuit board, hard disk, and various input devices.
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 "network gateway to a host of image management and printing devices" and provides "network access for both point -to - point and network capable image and information sources." It focuses on managing and routing medical images, not on performing tests on biological samples to diagnose diseases or conditions.
- Device Description: The components listed are typical for a computer system designed for image management and networking, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or any processes related to in vitro testing.
The device is described as a system for managing and routing medical images, which falls under the category of medical imaging devices or Picture Archiving and Communication Systems (PACS) components, not IVDs.
N/A
Intended Use / 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.
Product codes
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Device Description
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
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K-931551
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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
1
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) |
| Power | ||
| Requirements | 90-132VAC/47-63Hz | |
| 180-264VAC/47-63Hz | 100VAC +/-10%,50/60 Hz (+/-2%)250w | |
| 120VAC +/-10%,60Hz (+/-2%)250w | ||
| 220VAC +/-10%,50/60 Hz (+/-2%)250w | ||
| 240VAC +/-10%,50/60 Hz (+/-2%)250w | ||
| Environmental | 15-35 degrees C / 15-90% RH | |
| non-condensing | 41-95 degrees F / 15-80% RH | |
| non-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/CCIR | ||
| Red,Green,Blue (RGB) | Monochrome: | |
| RS-170/CCIR | ||
| Red,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: |