← Product Code [LMD](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMD) · K960382 # KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER (K960382) _Eastman Kodak Company · LMD · Apr 17, 1996 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMD/K960382 ## Device Facts - **Applicant:** Eastman Kodak Company - **Product Code:** [LMD](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMD.md) - **Decision Date:** Apr 17, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2020 - **Device Class:** Class 1 - **Review Panel:** Radiology ## 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. ## Regulatory 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](/device/K931551.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGE Premarket Notification: 510(k) 15960382 K960382 # SUMMARY OF SAFETY AND EFFECTIVENESS ## I. INTRODUCTION The KODAK Digital Science Medical Image Manager is an extension of the KODAK Health Sciences Imagelink System with the intended use to be used as a network gateway to a host of image management and printing devices. ## II. GENERAL INFORMATION **Name of Manufacture:** Eastman Kodak Company Health Sciences Division 18325 Waterview Parkway Dallas, Texas 75252-8026 **Establishment Registration Number:** **Device Name:** KODAK Digital Science Medical Image Manager **Device Classification:** Class 1 Device ## III. THE DEVICE The general hardware configuration of the KODAK digital Science Medical Imager contains the following major components: - Power Supply - Main System Circuit Board - Hard Dick - Internal Removable Media - Keypad **Optional Accessories:** - Keypad Accessories - Mini-keypad - Microphone - Modality Store Connection - Keyboard - Bar Code Reader - Magnetic Stripe Reader APR 17 1996 {1} KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGE Premarket Notification: 510(k) IV. INDICATIONS FOR 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. ## V. COMPARISON OF FEATURES **KODAK EKTASCAN** **IMAGELINK** Ultrasound System **KODAK DIGITAL SCIENCE** Remote Network Interface ### General | K-Number | K-931551 | This 510(k) | | --- | --- | --- | | Power Requirements | 90-132VAC/47-63Hz 180-264VAC/47-63Hz | 100VAC +/-10%,50/60 Hz (+/-2%)250w 120VAC +/-10%,60Hz (+/-2%)250w 220VAC +/-10%,50/60 Hz (+/-2%)250w 240VAC +/-10%,50/60 Hz (+/-2%)250w | | Environmental | 15-35 degrees C / 15-90% RH non-condensing | 41-95 degrees F / 15-80% RH non-condensing | ### Acquisition Unit | Removable Disk | 2.5” Hard Disk | 3.5” Floppy, 3.5” Magneto Optical (MOD) | | --- | --- | --- | | Disk Storage Capacity | 30,40,60,80,105 Mbytes | 1-4 GBytes | | Network Capability | Ethernet | Ethernet | | Video Image Inputs | Monochrome: RS-170/CCIR Red,Green,Blue (RGB) | Monochrome: RS-170/CCIR Red,Green,Blue (RGB), CINE Loop, Motion Video | | Digital Image Inputs | None | 8 and 12 Bit Digital Images in UBMED Format | | Serial Control Inputs | None | RS-232, RS-422 | | Image Capture Time | 1/30 second (.25MB) | Grayscale Video: .2s (1MB) Color Video: .25s(1MB) 8-Bit Digital: .2s (1MB) | | Image Store Time | Grayscale Video: <2 seconds (.25MB) Color Video: <5 seconds (.75MB) | Grayscale Video: .5s (1MB) Color Video: 1.5s (3MB) 8-Bit Digital: .5s (1MB) | ### Reader Unit | Inputs | Removable Disk Cartridge Ethernet - ACR/NEMA Format | 3.5” Floppy, 3.5” Magneto Optical Ethernet - DICOM Format, HIS/RIS Interface | | --- | --- | --- | | Outputs | SCSI, Video, RS-485, RS-422, RS-232 | Ethernet, RS-485, High Speed Optical, Modem, ATM, SCSI | | Image Presentation | 1,2,4,6,8,9,12,15,16,20,24,30,35 | 1,2,4,6,8,9,12,15,16,20,24,30,35,slide | --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMD/K960382](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMD/K960382) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com