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.

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.

AI/ML Overview

This 510(k) summary describes a Picture Archiving and Communications Systems (PACS) Component, specifically the KODAK Digital Science Medical Printer Interface Unit (K961740) and its associated Medical Modality Acquisition Unit. The document explicitly states it is a comparison to a predicate device and does not contain information about acceptance criteria or a study proving the device meets said criteria.

The document is a "510(k) SUMMARY OF SAFETY AND EFFECTIVENESS" for a medical device that has been classified as Class II, a classification for devices that are considered to pose a moderate risk to patients and thus require general and special controls to assure their safety and effectiveness.

The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This is primarily achieved through a "comparison of features" table, as provided in the document.

Therefore, I cannot provide the requested information because it is not present in the provided text. The document focuses on establishing substantial equivalence to a predicate device based on features and intended use, rather than presenting acceptance criteria and performance study results.

Summary

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K961740

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:

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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).

V. COMPARISON OF FEATURES:

Characteristics	KODAK Digital ScienceMedical ModalityAcquisition Unit andPrinter Interface Unit	KODAK EktascanImagelink System
Knumber	this submission	K931551
GENERAL
Advertised use	Productivity improvement,eliminate film cassettes anddarkroom processing, eliminateneed to sterilize film cassettes	Productivity improvement,eliminate film cassettes anddarkroom processing, eliminateneed to sterilize film cassettes
Input modalitiesadvertised	C-Arm, Digital SubtractionAngiography, Nuclear Medicine,Ultrasound, and other videomodalities.	C-Arm, Digital SubtractionAngiography, NuclearMedicine, and Ultrasound
Power requirements	90-132vac/47-63Hz180-264vac/47-63Hz	90-132vac/47-63Hz180-264vac/47-63Hz
Environmental	4-45 degrees C/15-90% RHnon-condensing	4-45 degrees C/15-90% RHnon-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	1,2,4,6,8,9,12,15,16,24,35images per frame, plus slides	1,2,4,6,8,9,12,15,16,24,35images per frame, plus slides

SIDE-BY-SIDE COMPARISON TABLE

Regulation Number and Section

§ 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).