LASERSHARE PRINT SPOOLER AND/OR SOFTWARE

K963861 · Dejarnette Research Systems · LMD · Dec 18, 1996 · Radiology

Device Facts

• Record ID: K963861
• Device Name: LASERSHARE PRINT SPOOLER AND/OR SOFTWARE
• Applicant: Dejarnette Research Systems
• Product Code: LMD · Radiology
• Decision Date: Dec 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

The Lasershare Print Spooler and/or Software is a distributable filming management system that receives digital images and format control data from various image sources (including, but not limited to, CT scanners, MR scanners, Ultrasound systems, R/F units, Computed and Direct Radiography devices, secondary capture devices, imaging gateways, removable storage media or other imaging sources) connected point to point or via networks. The incoming data formats are standard medical imaging formats or proprietary to the modality source vendor. The Lasershare Print Spooler and/or Software allows the operator to manage print job requests, create filming sessions and route image and patient data to one or more laser film printers, thermal dye sublimation and dry printers and other medical imaging print devices.

Device Story

Lasershare Print Spooler is a software-based filming management system; accepts digital images and format control data from diverse medical imaging modalities (CT, MR, Ultrasound, etc.) via point-to-point or network connections. Operates on off-the-shelf general-purpose computing hardware; manages print job queues; routes image and patient data to laser film, thermal dye sublimation, or dry printers. Used in clinical environments by radiology staff to facilitate hard-copy output of diagnostic images. System is modular; network interfaces allow distribution across local or remote machines. Benefits include centralized print management and improved workflow efficiency for medical imaging departments.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Modular software system designed for portability across off-the-shelf general-purpose computing hardware and operating systems. Utilizes network interfaces for communication between modules. Functions as a digital imaging network spooler for print management.

Indications for Use

Indicated for management of medical imaging print jobs, creation of filming sessions, and routing of image/patient data from various modalities (CT, MR, Ultrasound, R/F, CR/DR) to medical imaging printers.

Regulatory Classification

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

• Imageshare 910
• SIENET CS Camera Server
• MergeAPS (MergeMVP)
• Resource Spooler
• VIPStation

Submission Summary (Full Text)

{0}

DEJARNETTE 510(k) Notification — Premarket Submission

# 1. 510(k) Summary

## 510(k) Summary

[As required by 21 CFR 807.92(c)]

KE963861
DEC 18 1996

## 1.0 Submitter Information

1.1 DeJarnette Research Systems
401 Washington Avenue Suite 700
Towson MD 21204

1.2 Contact: Wayne T. DeJarnette, Ph.D.
Voice: +1 (410) 583 - 0680
Fax: [phone] - 0696
E-mail: [e-mail]

1.3 Date Prepared: 24 September 1996

## 2.0 Device Identification

2.1 Trade Name: Lasershare Print Spooler and/or Software
2.2 Common Name: Digital Imaging Network Spooler
2.3 Classification Name: System, Digital Image Communication, accessory

## 3.0 Predicate Devices

Imageshare 910 [DeJarnette Research Systems, Inc.]
SIENET CS Camera Server [Siemens Medical Systems, Inc.]
MergeAPS (MergeMVP) [Merge Technologies, Inc.]
Resource Spooler [Analogic Corporation]
VIPStation [CEMAX, Inc.]

## 4.0 Device Description

### 4.1 Function:

The Lasershare Print Spooler is designed to accept images from various modalities or digital image networks and direct images to one or more medical imaging print devices, providing spooling and queue management facilities.

Core technology for the Lasershare Print Spooler is based on, and various software components ported from, the Imageshare 910 Protocol Converter (a predicate device). The Lasershare is a modular system that uses network interfaces for communication between the modules. Network interfaces enable the various modules to reside on local or remote machines.

### 4.2 Physical and Performance Characteristics:

The Lasershare Print Spooler and/or Software is designed to run on off-the-shelf, general purpose computing equipment. The application software is designed for maximum portability across operating systems and hardware platforms. Performance of the application software is primarily a function of network load; secondarily a function of the hardware platform’s computational speed and finally the performance of the printer(s). Intrinsic performance of the application does not change significantly as it is ported from one operating system to another.

401 Washington Avenue, Suite 700
Towson, Maryland 21204
Tel.: [phone] Fax: [phone]
[DRS-KQ0006-xxx] Page 1-1

{1}

DEJARNETTE 510(k) Notification — Premarket Submission

## 5.0 Intended Use:

The Lasershare Print Spooler and/or Software is a distributable filming management system that receives digital images and format control data from various image sources (including, but not limited to, CT scanners, MR scanners, Ultrasound systems, R/F units, Computed and Direct Radiography devices, secondary capture devices, imaging gateways, removable storage media or other imaging sources) connected point to point or via networks. The incoming data formats are standard medical imaging formats or proprietary to the modality source vendor. The Lasershare Print Spooler and/or Software allows the operator to manage print job requests, create filming sessions and route image and patient data to one or more laser film printers, thermal dye sublimation and dry printers and other medical imaging print devices.

## 6.0 Statement of Substantial Equivalence:

The Lasershare Print Spooler and/or Software is substantially equivalent to previously marketed devices (as listed above in Part 3) in design, composition, function, intended use, safety and efficacy.

Any differences between the Lasershare Print Spooler and/or Software and the predicate devices have no significant influence on safety or efficacy.

401 Washington Avenue, Suite 700
Towson, Maryland 21204
Tel.: [phone] Fax: [phone]
[DRS-KQ0006-xxx] Page 1-2