LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT])

K973422 · Dejarnette Research Systems · LMC · Oct 28, 1997 · Radiology

Device Facts

• Record ID: K973422
• Device Name: LASERSHARE PRINT SPOOLER(2100[SOLARIS X86]/(1500[WINDOWS NT])
• Applicant: Dejarnette Research Systems
• Product Code: LMC · Radiology
• Decision Date: Oct 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2040
• Device Class: Class 2
• 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 various medical imaging modalities (CT, MR, Ultrasound, etc.) via point-to-point or network connections. System provides spooling, queue management, and routing of image/patient data to laser film, thermal dye sublimation, or dry printers. Operates on off-the-shelf general-purpose computing hardware; modular architecture allows components to reside on local or remote machines. Used by clinical staff to manage print job requests and create filming sessions. Facilitates efficient hard-copy production of medical images for diagnostic review.

Clinical Evidence

No clinical data; bench testing only. The device is a software port of a previously marketed system, with performance verified through functional assessment of the spooling and routing capabilities across hardware platforms.

Technological Characteristics

Modular software system; runs on off-the-shelf general-purpose computing hardware. Uses network interfaces for communication between modules. Supports standard and proprietary medical imaging data formats. Designed for portability across operating systems.

Indications for Use

Indicated for use as a filming management system to receive, manage, and route digital medical images from various imaging modalities (CT, MR, Ultrasound, R/F, CR/DR) to medical imaging print devices for clinical printing.

Regulatory Classification

Identification

A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.

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). 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

• Lasershare Print Spooler and/or Software (DeJarnette Research Systems, Inc.)

Submission Summary (Full Text)

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# 973422

## 1. 510(k) Summary

1 0

## 510(k) Summary

[As required by 21 CFR 807.92(c)]

OCT 28 1997

| 1.0 | Submitter Information | | | | | |
|-----|-----------------------------------------------------------------------------------|------------------|-----|---------------------------------------|----------------------------------------------------------------------------------------|--|
| 1.1 | DeJarnette Research Systems<br>401 Washington Avenue Suite 700<br>Towson MD 21204 | | 1.2 | Contact:<br>Voice:<br>Fax:<br>E-mail: | Eric John Finegan<br>+1 (410) 583 - 0680<br>+1 (410) 583 - 0696<br>[e-mail] | |
| 1.3 | Date Prepared: | 8 September 1997 | | | | |

#### Device Identification 2.0

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

#### 3.0 Predicate Devices

Lasershare Print Spooler and/or Software [DeJarnette Research Systems, Inc.]

#### Device Description 4.0

- Function: 4.1
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.

The Lasershare Print Spooler and/or Software is a different model of the current Lasershare Print Spooler and/or Software [predicate device], ported to another operating system. 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.

### Physical and Performance Characteristics: 4.2

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.

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## EJARNETTE

#### Intended Use: 5.0

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 the previously marketed device (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.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 28 1997

Wayne T. DeJarnette, Ph.D. President, DeJarnette Research Systems, Inc. 401 Washington Avenue Suite 700 Towson, MD 21204

Re: K973422

Lasershare Print Spooler Dated: September 8, 1997 Received: September 10, 1997 Unclassified Procode: 90 LMC

Dear Dr. DeJarnette:

We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the inclosure) to devices marketed in interstate in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 OS 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 marketed 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 yitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W. Niau 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

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## 2. Statement of Indications for Use

Device: Lasershare Print Spooler and/or Software

## Statement of Indications for Use

[As required by 21 CFR 801.109]

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Garold A. Heggen
(Division Sign-Off)

Division of Reproductive, Abde ... ENT, and Radiological Devic 510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)
✓

OR

Over-The-Counter Use