(57 days)
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.
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
This document, K962896, describes the KODAK Digital Science Remote Cassette Identification Station (RCIS). It is an accessory device designed to manage patient and exam information within the KODAK Ektascan Image Link Model 400 System.
Unfortunately, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics (e.g., accuracy, sensitivity, specificity) for an AI or imaging device's clinical application.
The document primarily focuses on:
- Introduction and General Information: Device name, manufacturer, classification.
- Device Description: Hardware components (touch screen monitor, CPU, bar-code reader).
- Indication for Use: How the device functions within the overall system to transmit and update patient/exam information.
- Regulatory & Consensus Standard Compliance: This section details safety and electromagnetic compatibility (EMC) standards the device adheres to (e.g., UL, CSA, IEC, EN, FCC). These are product safety and manufacturing compliance standards, not clinical performance acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as this information is not present in the provided text. The device described is an information management accessory, not an AI or diagnostic imaging device that would typically have such performance criteria.
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SEP 2 0 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
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.
11. 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
- Identification, Marking and Documents 6.
-
- Continuous Leakage Currents
-
- Dielectric Strength
- 44.3 Spillage
- Creepage Distances and Air Clearances 57.10
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.
મ
§ 892.1680 Stationary x-ray system.
(a)
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.(b)
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.