KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER
Device Facts
| Record ID | K960382 |
|---|---|
| Device Name | KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER |
| Applicant | Eastman Kodak Company |
| Product Code | LMD · Radiology |
| Decision Date | Apr 17, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2020 |
| Device Class | Class 1 |
Intended Use
The KODAK Digital Science Medical Image Manager will provide network access for both point-to-point and network capable image and information sources. The Image Manager will provide a value added service to point-to-point devices by adding services including routing to multiple destinations and access to multiple printers. However, evaluation of soft copy or hard copy output provides adequate opportunity for competent human intervention. PACS are not represented to be used in supporting or sustaining human life, nor do they represent a potential for unreasonable risk of illness or injury.
Device Story
Device functions as network gateway/image manager for medical imaging systems. Inputs include monochrome/RGB video (RS-170/CCIR), CINE loops, motion video, and 8/12-bit digital images (UBMED format). Operates via internal system board, hard disk, and removable media (floppy/magneto-optical). Provides routing to multiple destinations and printer access. Used in clinical environments; operated by healthcare staff. Output consists of routed image data for soft/hard copy review. Facilitates workflow by enabling connectivity between disparate imaging sources and output devices. Human intervention required for clinical evaluation of images.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Hardware includes power supply, main system circuit board, hard disk, removable media (3.5" floppy/magneto-optical), and keypad. Connectivity via Ethernet, RS-232, RS-422, RS-485, SCSI, Modem, and ATM. Supports DICOM and HIS/RIS interfaces. Power requirements: 100-240VAC, 50/60Hz. Environmental operating range: 41-95 degrees F, 15-80% RH.
Indications for Use
Indicated for use as a network gateway for image management and printing devices, providing network access for point-to-point and network-capable image and information sources. No specific patient population, age, or disease state contraindications are defined.
Regulatory Classification
Identification
A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.
Predicate Devices
- KODAK EKTASCAN IMAGELINK Ultrasound System (K931551)
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