KODAK DIGITAL SCIENCE MEDICAL PRINTER INTERFACE UNIT
Device Facts
| Record ID | K961740 |
|---|---|
| Device Name | KODAK DIGITAL SCIENCE MEDICAL PRINTER INTERFACE UNIT |
| Applicant | Kodak Health Imaging Systems, Inc. |
| Product Code | LLZ · Radiology |
| Decision Date | Nov 14, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
Indications for Use
The KODAK Ektascan Imagelink System (KEIS) is a DICOM conferment product designed for use within a Picture Archiving and Communication System (PACS). 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 Story
The KODAK Digital Science Medical Printer Interface Unit and Modality Acquisition Unit function as components of a PACS. The system accepts inputs from medical imaging modalities (C-Arm, DSA, Nuclear Medicine, Ultrasound) via monochrome (RS-170/CCIR) or RGB video signals. The Acquisition Unit captures images (1/30s) and stores them on a 2.5" hard drive. The Printer Interface Unit processes data via Ethernet or removable disk, supporting DICOM v3.0 (ACR-NEMA) formats. Outputs include SCSI, video, and serial interfaces (RS-485, RS-422, RS-232) for printing or display. Used in clinical settings by healthcare professionals to manage diagnostic images, the system eliminates film cassettes and darkroom processing, improving workflow efficiency. Human intervention is required for the evaluation of soft or hard copy output to support clinical decision-making.
Clinical Evidence
No clinical data provided; bench testing only. The device is a PACS component evaluated based on technical performance specifications and functional equivalence to the predicate system.
Technological Characteristics
System components include a 2.5" hard drive for storage, Ethernet connectivity, and multiple serial/video output ports (SCSI, RS-485, RS-422, RS-232). Supports DICOM v3.0 (ACR-NEMA) standards. Operates on 90-132vac/180-264vac (47-63Hz). Environmental specs: 4-45°C, 15-90% RH non-condensing. Image presentation supports multi-format layouts (1 to 35 images per frame).
Indications for Use
Indicated for use within a PACS environment for the management of diagnostic image information, including image acquisition, printing, review, archive/retrieval, and communications from modalities such as C-Arm, Digital Subtraction Angiography, Nuclear Medicine, Ultrasound, and other video modalities.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
- KODAK Ektascan Imagelink System (K931551)
