KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY

K960981 · Kodak Health Imaging Systems, Inc. · LMB · Jun 7, 1996 · Radiology

Device Facts

• Record ID: K960981
• Device Name: KODAK DIGITAL SCIENCE(KDS) MEDICAL IMAGE AND INFORMATION LIBRARY
• Applicant: Kodak Health Imaging Systems, Inc.
• Product Code: LMB · Radiology
• Decision Date: Jun 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2010
• Device Class: Class 1

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 algorithm to facilitate fast access to previous imagery.

Device Story

KDS Medical Image and Information Library (MIIL) functions as a DICOM-conformant image storage, distribution, and library system within a PACS environment. System components include a Sun SPARC host CPU, magnetic RAID cache, and KODAK DIGITAL SCIENCE ADL 150 writeable CD jukebox. Hierarchical storage library software manages RAID and CD subsystems as a single filesystem. Device inputs include medical images via DICOM; system uses prefetching algorithm to optimize retrieval speed for previous imagery. Output consists of stored/retrieved medical images for clinical review. Operated by radiology staff/technicians in clinical settings. Facilitates efficient image management and access to historical patient data to support clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System architecture: Sun SPARC station 5 or 20 host CPU, Sun SPARC storage Array RAID subsystem, KODAK DIGITAL SCIENCE ADL 150 writeable CD jukebox. Interface: SCSI. Media: 5.25" CD-Recordable. Power: 100-240 VAC, 50/60 Hz. Connectivity: DICOM conformant, HIS/RIS interface. Software: Proprietary hierarchical storage library management.

Indications for Use

Indicated for use within a Picture Archiving and Communication System (PACS) for the archival, storage, and retrieval of medical images.

Regulatory Classification

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

• Vortech (Kodak) Image Archive and Retrieval System (K915094)

Submission Summary (Full Text)

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KODAK DIGITAL SCIENCE
Premarket Notification
K960981
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
JUN - 7 1996

I. DATE PREPARED: March 4, 1996

II. SUBMITTER:
Eastman Kodak Company
Health Imaging Division
Medical Imaging Systems
18325 Waterview Parkway
Dallas, Texas 75252-8026

III. CONTACT PERSON:
Stan E. Tillman
Director, Regulatory Affairs
[phone]

IV. DEVICE NAME:
Trade Name - KODAK DIGITAL SCIENCE (KDS) Medical Image and Information Library (MIIL)
Common Name - Image Storage, Distribution, and Library

V. DEVICE CLASSIFICATION
FDA has classified the predicate device as Regulatory Class II under 21 CFR 892.1750.

VI. PREDICATE DEVICE
Vortech (Kodak) Image Archive and Retrieval System--K915094

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KODAK DIGITAL SCIENCE

Premarket Notification

# VII. DESCRIPTION OF DEVICE

The system consists of three main components: 1) the host CPU (a Sun SPARC station 5 or 20) with pre-installed proprietary software, 2) the magnetic cache (a Sun SPARC storage Array RAID subsystem), and 3) a KODAK DIGITAL SCIENCE ADL 150 writeable CD jukebox. The RAID subsystem and the CD jukebox 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.

# VIII. INDICATIONS FOR 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 algorithm to facilitate fast access to previous imagery.

# V. COMPARISON OF FEATURES

SIDE-BY-SIDE COMPARISON TABLE

| Item | Description | Price |
| --- | --- | --- |
| K-number | This 510(k) | K915094 |
| Range of Storage | 8GB to 216GB | 37GB to 1.4TB |
| Type of Interface | SCSI | SCSI |
| Type of Media | 5.25" CD-Recordable | 12" WORM Platters |
| DICOM Conformant | Yes, Native | No |
| HIS/RIS Interface | Yes | No |
| Host Platform | Sun | Sun |
| Jukebox, Maximum | Yes, 150-CD | Yes, 140-Platters |
| Compression | Yes, lossless 2:1 | Yes, lossless 2:1 |
| Database Structure | Distributed | Distributed |

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