← Product Code [LMB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB) · K972380 # KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) (K972380) _Eastman Kodak Company · LMB · Sep 11, 1997 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K972380 ## Device Facts - **Applicant:** Eastman Kodak Company - **Product Code:** [LMB](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB.md) - **Decision Date:** Sep 11, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2010 - **Device Class:** Class 1 - **Review Panel:** Radiology ## Intended Use The KODAK DIGITAL SCIENCE (KDS) Medical Image and Information Library is a DICOM conformant archival product designed for use within a Picture Archiving and Communication System (PACS). The system utilizes a prefetching Archiving and Sommercess to previous imagery. ## Device Story The KODAK DIGITAL SCIENCE (KDS) Medical Image and Information Library (MIL) is a PACS archival storage device. It functions as a hierarchical storage library, managing medical images and information within a clinical PACS environment. The system inputs include DICOM-compliant medical images; it utilizes a host CPU (Sun SPARCstation) running proprietary software to manage data storage across a magnetic cache (RAID subsystem) and long-term storage media (CD jukebox or Digital Linear Tape library). The device provides lossless (2:1) or lossy (up to 50:1) compression. It interfaces with Hospital Information Systems (HIS) and Radiology Information Systems (RIS). The system presents the combined storage subsystems as a single large filesystem. Healthcare providers use the archived data for clinical review and prefetching of previous imagery to support diagnostic decision-making. The device is intended for professional use in clinical settings. ## Clinical Evidence Bench testing only. No clinical data provided. ## Technological Characteristics System components: Sun SPARCstation host CPU, RAID magnetic cache, and CD/DLT jukebox storage. Connectivity: SCSI interface, DICOM conformant. Power: 100-240 VAC, 50/60 Hz. Software: Proprietary archival management software. Compression: Lossless 2:1 or lossy up to 50:1. Storage capacity: 12 GB to 20 TB. ## Regulatory Identification A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory. ## Predicate Devices - Kodak Digital Science Medical Image and Information Library ([K960981](/device/K960981.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}------------------------------------------------ # SEP 11 1997 #### Safety and Effectiveness Information 7.0 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS X972380 - DATE PREPARED: June 23, 1996 I. #### SUBMITTER: II. Eastman Kodak Company Health Imaging Division 18325 Waterview Parkway Dallas, Texas 75252-8026 #### CONTACT PERSON: III. Stan E. Tillman Director, Regulatory Affairs Health Imaging Division, Dallas (972) 454-1642 - IV. DEVICE NAME: Trade Name - KODAK DIGITAL SCIENCE™ (KDS) Medical Image and Information Library (MIL) Common Name - PACS Storage Device (Archive) - V. DEVICE CLASSIFICATION FDA has classified the predicate device as Regulatory Class II under 21 CFR 892.1750. - VI. PREDICATE DEVICE Kodak Digital Science Medical Image and Information Library--K960981 - VII. DESCRIPTION OF DEVICE The system consists of three main components: 1) the host CPU (a Sun SPARCstation 5, SPARCstation 20, or UltraSparc) with pre-installed proprietary software, 2) the magnetic cache, a Sun SPARC storage Redundant Array of Inexpensive Disks (RAID) subsystem, and 3) a KODAK DIGITAL SCIENCE ADL 150 writeable CD jukebox or a Digital Linear Tape (DLT) library. The RAID subsystem, combined with either the CD jukebox or DLT library, are managed by a hierarchical storage library that presents these two subsystems to the system software running on the host CPU as a single, very large filesystem. The power supply provides power to operate the unit from a line voltage for 100, 120, 220, or 240 VAC, 50/60 Hz. {1}------------------------------------------------ KODAK DIGITAL SCIENCE Premarket Notification #### INDICATIONS FOR USE VIII. The KODAK DIGITAL SCIENCE (KDS) Medical Image and Information Library is a DICOM conformant archival product designed for use within a Picture Archiving and Communication System (PACS). The system utilizes a prefetching Archiving and Sommercess to previous imagery. ### COMPARISON OF FEATURES V. | K-number | This 510(k) | K960981 | |--------------------|--------------------------------------------------------|---------------------| | Range of Storage | 12 GB - 20 TB | 8 GB to 216 GB | | Type of Interface | SCSI | SCSI | | Type of Media | 5.25" CD-Recordable
or
Digital Linear Tape (DLT) | 5.25" CD-Recordable | | Jukebox, Maximum | Yes, 150-CD
or
588 DLT Cartridges | Yes, 150-CD | | Compression | Yes, lossless 2:1
or
lossy to 50:1 | Yes, lossless 2:1 | | DICOM Conformant | Yes, Native | Yes, Native | | HIS/RIS Interface | Yes | Yes | | Host Platform | Sun | Sun | | Database Structure | Distributed | Distributed | 6/97 {2}------------------------------------------------ Image /page/2/Picture/16 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes. Public Health Service Rockville MD 20850 Food and Drug Administration 9200 Corporate Boulevard ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ 1997 Stan E. Tillman Director, Regulatory Affairs Eastman Kodak Company Health Imaging Division Medical Imaging Systems 18325 Waterview Parkway Dallas, Texas 75252 Re: K972380 "Kodak Digital Science™ Medical Image Archive" Dated: June 23, 1997 Received: June 26, 1997 Regulatory class: Unclassified Procode: 90 LMB Dear Mr. Tillman: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, W.Liau Yu Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(k) Number (if known): _K9723 3 80 Device Name: Kodak Digital Science™ Medical Image and Information Library (MIIL) INDICATION FOR USE: ﻨﻴﻨﺘﺎ ﺴﻴﺔ DICOM conformant archival product (storage library) designed for use within a Picture Archiving and Communications System (PACS). ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CRF 801.109) OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Elinil A. Segerson (Optional Format 1-2-96) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K972380 2 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K972380](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LMB/K972380) **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