KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER)

K961768 · Kodak Health Imaging Systems, Inc. · LMA · Aug 22, 1996 · Radiology

Device Facts

• Record ID: K961768
• Device Name: KODAK DIGITAL SCIENCE FILM DIGITIZER L7501/L7506 (WITH FILM AUTOFEEDER)
• Applicant: Kodak Health Imaging Systems, Inc.
• Product Code: LMA · Radiology
• Decision Date: Aug 22, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Intended Use

The KDS FD is designed to allow operators and physicians greater access to images by transmitting them electronically over networks instead of physically sending films. The system allows for much quicker consultations with experts in distant facilities. Also, archiving electronically for faster image recall and assembly of historical studies can be accomplished with ease. The KDS FD is a DICOM conformant digitization product designed for use within a Picture Archiving and Communication System (PACS).

Device Story

System converts X-ray films into digital images; utilizes Lumisys laser film digitizer; integrates into PACS via DICOM standard. Operated by clinical staff; digitizes film for electronic transmission over LAN/WAN. Enables remote expert consultation, rapid image recall, and historical study assembly. Supports manual patient data entry or HIS/RIS interface for demographic capture. Output viewed on digital monitors; assists clinicians in diagnostic review and workflow efficiency.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence based on technological similarity and functional performance of laser digitizer components.

Technological Characteristics

Lumisys laser film digitizer; DICOM conformant; supports LAN/WAN connectivity; HIS/RIS interface capability. System architecture includes image preview software.

Indications for Use

Indicated for use in clinical environments to digitize X-ray films for electronic display, transmission, and archiving within a PACS, facilitating remote consultations and historical study management.

Regulatory Classification

Identification

A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Kodak Film Digitizer (K915362)

Submission Summary (Full Text)

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AUG 22 1996
K961768

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

I. DATE PREPARED: May 3, 1996

II. SUBMITTER:

Eastman Kodak Company
Health Imaging Division
18325 Waterview Parkway
Dallas, Texas 75252-8026

III. CONTACT PERSON:

Edward A. Weaver
Regulatory Affairs
[phone]

IV. DEVICE NAME:

Trade Name
KODAK Digital Science Film Digitizer L7501
KODAK Digital Science Film Digitizer L7506 (with Film Autofeeder)

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 Film Digitizer ("FD")

VII. DESCRIPTION OF DEVICE:

Kodak’s Film Digitizer (KODAK DIGITAL SCIENCE Film Digitizer or KDS FD) is a system designed to convert X-ray films into digital images for display, transmission, and/or archiving. The KDS FD is designed to accomplish its interface over the American College of Radiology-National Electrical Manufacturers Association (ACR-NEMA) standard known as DICOM (Digital Imaging and Communications in Medicine) which gives direct access to imaging devices, Local Area Networks (LANs), and Wide Area Networks (WANs).

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# VIII. INDICATIONS FOR USE:

The KDS FD is designed to allow operators and physicians greater access to images by transmitting them electronically over networks instead of physically sending films. The system allows for much quicker consultations with experts in distant facilities. Also, archiving electronically for faster image recall and assembly of historical studies can be accomplished with ease. The KDS FD is a DICOM conformant digitization product designed for use within a Picture Archiving and Communication System (PACS).

# IX. Substantial Equivalence

The purpose and functionality of the KDS FD is substantially similar to the Vortech (Kodak) FD system (K915362, November 27, 1991), as well as numerous other x-ray digitizers currently on the market. The basis for the equivalence is that both systems consist of a Lumisys laser film digitizer with image preview software with similar functionality.

Each system performs high definition scanning of images on film for display on monitors. The level of clarity and definition is similar. The ability to input and tie in patient information to complete records is similar -- the FD allowed for manual data entry only whereas the KDS FD allows for manual data entry or an interface into a HIS/RIS to capture patient demographic data.

The transmission of the images across networks is also supported by both systems. Kodak used ACR-NEMA 2.0 for the FD and will use DICOM for the KDS FD. The function of image routing is supported by both systems.

The only real difference in the systems is the choice of hardware. Both systems use reliable, mature components. The software and system functionalities are comparable with few minor exceptions in patient information fields and networking options.

Based on the similarity of the purpose and functionalities of these two systems, Kodak concludes that the KODAK DIGITAL SCIENCE Film Digitizer is substantially equivalent to the Kodak Film Digitizer.