KODAK DIGITAL SCIENCE REMOTE CASSETTE

K962896 · Eastman Kodak Company · KPR · Sep 20, 1996 · Radiology

Device Facts

• Record ID: K962896
• Device Name: KODAK DIGITAL SCIENCE REMOTE CASSETTE
• Applicant: Eastman Kodak Company
• Product Code: KPR · Radiology
• Decision Date: Sep 20, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The user will enter Exam Information and/or display Patient information from HIS/RIS at one of the RCIS terminal(s). This information will be transmitted via a network to the primary Quality Control Workstation of the CR-400 System. The primary QCW will update other QCW's and their respective KESPR Readers. After the phosphor cassette containing the Latent Image is scanned by a KESPR Reader the images are transmitted to a workstation which allows for the proper display of the images for diagnostic purposes. The information stored in the Readers and the will be updated by removing Exam and Patient Information. The phosphor readers are not for supporting or sustaining human life, nor do they present a potential for unreasonable risk for illness or injury.

Device Story

KODAK Digital Science Remote Cassette Identification Station (RCIS) functions as accessory to KESPR and QCW components of KODAK Ektascan Image Link Model 400 System. Hardware includes touch screen monitor, CPU, and bar-code reader. Used by clinical staff to input exam/patient data or retrieve information from HIS/RIS. Data transmitted via network to primary Quality Control Workstation (QCW) to update KESPR readers. Facilitates association of patient/exam data with latent images on phosphor cassettes prior to scanning. Enables diagnostic image display workflow. Does not support/sustain life.

Clinical Evidence

Bench testing only. Compliance with safety and EMC standards including UL 1950, CSA C22.2 950-M89, IEC 950, IEC 60601-1, and various EN/IEC EMC standards.

Technological Characteristics

Hardware: touch screen monitor, CPU, bar-code reader. Networked connectivity for data transmission to QCW. Safety standards: UL 1950, CSA C22.2 950-M89, IEC 950, IEC 60601-1. EMC compliance: EN 55022, EN 50082-1, IEC 801-2/3/4, FCC Part 15. Seismic compliance: California Admin Code Title 22/24.

Indications for Use

Indicated for clinical environments requiring entry and display of patient and exam information for integration with KODAK Ektascan Image Link Model 400 System CR-400 phosphor cassette readers.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Reference Devices

• KESPR
• QCW
• KODAK Ektascan Image Link Model 400 System

Submission Summary (Full Text)

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K962896

SEP 20 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

## I. INTRODUCTION

The KODAK Digital Science Remote Cassette Identification Station(RCIS) is an accessory to the KESPR and the QCW. RCIS will allow the user to enter exam information and patient information at a separate RCIS terminal(s) so that the information is available to all the components of the KODAK Ektascan Image Link Model 400 System.

## II. GENERAL INFORMATION

**Name of Manufacturer**

EASTMAN KODAK COMPANY
Health Imaging Division
901 Elmgrove Road
Rochester New York 14653

**Established Registration Number**

1319085

**Device Name:**
- KODAK Digital Science Remote Cassette Identification Station

**Device Classification**
Class II Device

## III. THE DEVICE

The general hardware configuration of the KODAK Digital Science Remote Cassette Identification Station contains the following major components,
- Touch screen monitor
- Central Processing Unit(CPU)
- Bar-code reader

## IV. INDICATION FOR USE

The user will enter Exam Information and/or display Patient information from HIS/RIS at one of the RCIS terminal(s). This

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information will be transmitted via a network to the primary Quality Control Workstation of the CR-400 System. The primary QCW will update other QCW's and their respective KESPR Readers. After the phosphor cassette containing the Latent Image is scanned by a KESPR Reader the images are transmitted to a workstation which allows for the proper display of the images for diagnostic purposes. The information stored in the Readers and the will be updated by removing Exam and Patient Information. The phosphor readers are not for supporting or sustaining human life, nor do they present a potential for unreasonable risk for illness or injury.

## V. REGULATORY & CONSENSUS FOR STANDARD COMPLIANCE

### Safety:

Underwriters Laboratories Inc., #1950, Standard for Safety Of Information Technology Equipment, including Electrical Equipment.

Canadian Standards Association C22.2, 950-M89 Data Processing Equipment.

IEC Standard 950:1991 / EN 60950:8.1992 + A1:1.1993, Safety of Information Technology Equipment including Electrical Business Equipment.

IEC Standard 601-1:1988 / EN 60601-1, Medical Electrical equipment, Part

1: General requirements, sections
6. Identification, Marking and Documents
19. Continuous Leakage Currents
20. Dielectric Strength
44.3 Spillage
57.10 Creepage Distances and Air Clearances

### Electromagnetic Capability

EMC Directive (89/336/EEC) - ITE Equipment

EN 55022 (87) Class B

EN 50082-1

EN61000-3-2 Power Line Harmonics

EN61000-3-2 Flicker

IEC 801-2 (91) Electrostatic Discharge, severity level 4

IEC 801-3 (84) Radio Frequency Immunity, severity level 2

IEC 801-4 (88) Electrical Fast Transient, severity level 2

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FCC 47 CFR, Part 15, Subpart B, Class A

**Seismic**

California Administration Code, Title 22, Division 7 and Title 24, Part 2.