← Product Code [LLZ](/productcode/LLZ) · K961739 # KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT (K961739) _Kodak Health Imaging Systems, Inc. · LLZ · Nov 14, 1996 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K961739 ## Device Facts - **Applicant:** Kodak Health Imaging Systems, Inc. - **Product Code:** [LLZ](/productcode/LLZ.md) - **Decision Date:** Nov 14, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology ## 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 System functions as PACS component for diagnostic image management; acquires, prints, reviews, archives, and communicates medical images. Inputs include video signals (RS-170/CCIR, RGB) from modalities like C-Arm, DSA, Nuclear Medicine, and Ultrasound. Acquisition unit captures images in 1/30 second; stores on 2.5" hard drives. Printer Interface Unit supports DICOM v3.0/ACR-NEMA formats. Used in clinical environments by healthcare professionals to replace film cassettes and darkroom processing. Output provided as soft or hard copy for clinician review; facilitates diagnostic decision-making by streamlining image workflow and eliminating manual film handling. ## Clinical Evidence Bench testing only. No clinical data provided. Equivalence established through comparison of technical specifications, performance characteristics, and intended use. ## Technological Characteristics System components: Digital Science Medical Modality Acquisition Unit and Printer Interface Unit. Connectivity: Ethernet, DICOM v3.0/ACR-NEMA. Inputs: Monochrome RS-170/CCIR, RGB video. Storage: 2.5" hard drives (30, 60, 80, 105 Mbytes). Outputs: SCSI, Video, RS-485, RS-422, RS-232. Power: 90-132vac/47-63Hz or 180-264vac/47-63Hz. Environmental: 4-45 degrees C, 15-90% RH non-condensing. ## Regulatory 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](/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} NOV-06-1996 17:42 KHIS REGULATORY +001 214 994 4100 P.05 NOV 14 1996 K961739 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS I. DATE PREPARED: April 30, 1996 Revised: November 11, 1996 II. SUBMITTER: Eastman Kodak Company Health Imaging Division 18325 Waterview Parkway Dallas, Texas 75252-8026 III. CONTACT PERSON: Nancy Butcher Regulatory Affairs (214) 454-1417 IV. DEVICE NAME: Trade Name: KODAK Digital Science Medical Modality Acquisition Unit (K961739) Common Name: Picture Archiving and Communications Systems (PACS) Components V. DEVICE CLASSIFICATION FDA has classified the predicate device as Regulatory Class II under 21 CFR 892.1750. VI. PREDICATE DEVICE: KODAK Ektascan Imagelink System VII. DESCRIPTION OF DEVICE: The KODAK Ektascan Imagelink System [KEIS] is composed of components common to all image management systems for image acquisition, printing, review, archive/retrieval, and communications. These components can be combined into customized solutions for the management of diagnostic image information. Evaluation of soft and or hard copy output provides adequate opportunity for competent human intervention. 13 {1} NOV-06-1996 17:43 KHIS REGULATORY +001 214 994 4122 5.05 ## VIII. 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. ## V. COMPARISON OF FEATURES: ### SIDE-BY-SIDE COMPARISON TABLE | Characteristics | KODAK Digital Science Medical Modality Acquisition Unit and Printer Interface Unit | KODAK Ektascan Imagelink System | | --- | --- | --- | | K number | this submission | K931551 | | GENERAL | | | | Advertised use | Productivity improvement, eliminate film cassettes and darkroom processing, eliminate need to sterilize film cassettes | Productivity improvement, eliminate film cassettes and darkroom processing, eliminate need to sterilize film cassettes | | Input modalities advertised | C-Arm, Digital Subtraction Angiography, Nuclear Medicine, Ultrasound, and other video modalities. | C-Arm, Digital Subtraction Angiography, Nuclear Medicine, and Ultrasound | | Power requirements | 90-132vac/47-63Hz 180-264vac/47-63Hz | 90-132vac/47-63Hz 180-264vac/47-63Hz | | Environmental | 4-45 degrees C/15-90% RH non-condensing | 4-45 degrees C/15-90% RH non-condensing | | Acquisition Unit | | | | Removable Disk | 2.5" Hard Drive | 2.5" Hard Drive | | Disk Storage Capacity | 105, 30, 60, 80 Mbytes | 30, 60 Mbytes | | Network Capability | Ethernet | Ethernet | | Video Inputs | Monochrome: RS-170/CCIR; Red, Green, Blue (RGB) | Monochrome: RS-170/CCIR; Red, Green, Blue (RGB) | | Image Capture Time | 1/30 second | 1/30 second | | Image Store Time | Less than 1 second | Less than 1 Second | | Printer Interface Unit | | | | Inputs | Removable Disk Cartridge, Ethernet, DICOM v3.0 format (ACR_NEMA) | Removable Disk Cartridge, Ethernet, DICOM v3.0 format (ACR_NEMA) | | Outputs | SCSI, Video, RS-485, RS-422, RS-232 | SCSI, Video, RS-485, RS-422, RS-232 | | Image Presentation | 1,2,4,6,8,9,12,15,16,24,35 images per frame, plus slides | 1,2,4,6,8,9,12,15,16,24,35 images per frame, plus slides | --- **Source:** [https://fda-staging.innolitics.com/device/K961739](https://fda-staging.innolitics.com/device/K961739) **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