(57 days)
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No
The summary describes a system for digital radiography image acquisition and display, focusing on hardware components and data flow. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the use of such technologies.
No
The device is described as a system for displaying images for diagnostic purposes and explicitly states that the "phosphor readers are not for supporting or sustaining human life". This indicates it is not used for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that images are displayed "for diagnostic purposes."
No
The device description explicitly lists hardware components (touch screen monitor, CPU, bar-code reader) as major components of the system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases or other conditions.
- Device Function: The description clearly states the device is part of a system for processing and displaying medical images (specifically, images from a phosphor cassette containing a latent image). It handles patient information, exam information, and image transmission and display for diagnostic purposes.
- Lack of Biological Sample Handling: There is no mention of the device interacting with or analyzing biological samples. Its function is centered around image acquisition, processing, and display.
Therefore, while this device is used in a medical context for diagnostic imaging, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
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Device Description
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. 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
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.
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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
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- 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.
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