DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)

K973411 · General Scanning, Inc. · LMA · Dec 4, 1997 · Radiology

Device Facts

• Record ID: K973411
• Device Name: DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)
• Applicant: General Scanning, Inc.
• Product Code: LMA · Radiology
• Decision Date: Dec 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Intended Use

The General Scanning model LD2800 laser film digitizer is intended to create copies of medical images stored on film when connected to a laser imager. It is intended for use in making copies of conventional x-ray films as well as films produced by imagers that fall in the ranges specified for size and optical density range detailed in the specifications.

Device Story

LD2800 laser film digitizer creates copies of medical images stored on film. Device utilizes laser light to scan film; measures transmitted light to extract image data; converts data into digital form; transmits data over digital link to laser imager for printing. System components include scanning laser, detection module, film transport, and electronics for control, calibration, and data transmission. Used in clinical environments to facilitate medical image reproduction.

Clinical Evidence

Bench testing only.

Technological Characteristics

Laser-based film scanning and detection module; film transport mechanism; electronic data conversion and transmission circuitry. Operates by measuring transmitted light through film. Connectivity via digital link to laser imager.

Indications for Use

Indicated for creating copies of conventional x-ray films and medical images stored on film for clinical use.

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

• Lumiscan 85LF
• Lumiscan 100 (K901423)
• Konica (K9337830)
• Nishimoto Sangyo ED-2000
• Nishimoto Sangyo ED-3500

Submission Summary (Full Text)

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K973411

## 510(k) SUMMARY 2.

f

| 2.1 | Company Name | General Scanning Inc. (GSI)<br>500 Arsenal Street<br>Watertown, MA 02172 USA | |
|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------|
| 2.2 | Contact Person | Walter J. Leslie<br>Phone # [phone] x197<br>Fax # [phone] | |
| 2.3 | Date | September 8, 1997 | DEC - 4 1997 |
| 2.4 | Device Name | | |
| | Classification Name | Image Digitizer | |
| | Classification Number | 90LMA - Radiology Device | |
| | Common Name | Film Digitizer | |
| | Trade/Proprietary Name | DigMi-2000 (Internal to GSI)<br>LD2800 (Marketing Name) | |
| 2.5 | Substantial Equivalence - Predicate Devices | | |
| | Lumiscan 85LF | | |
| | Lumiscan 100 | K901423 | |
| | Konica | K9337830 | |
| | Nishimoto Sangyo ED-2000 | | |
| | Nishimoto Sangyo ED-3500 | | |
| 2.6 | Device Description and "Statement of Indications For Use"<br>The General Scanning model LD2800 laser film digitizer is intended to<br>create copies of medical images stored on film when connected to a laser<br>imager. It is intended for use in making copies of conventional x-ray films<br>as well as films produced by imagers that fall in the ranges specified for<br>size and optical density range detailed in the specifications.<br><br>The digitizer utilizes laser light to scan the film, extracts the image data by<br>measuring the transmitted light, converts it into digital form, and transmits<br>the data over a digital link. A laser imager may then be used to print a<br>copy of the original image.<br><br>The LD2800 contains the scanning laser and detection module, a film<br>transport, and electronics to convert and transmit the image data and<br>provide control and calibration. | | |

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN" are arranged in a semi-circle around the left side of the eagle.

DEC - 4 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Walter M. Leslie Engineering Manager Optical Scanning Products Division General Scanning, Inc. 500 Arsenal Street Watertown, MA 02172

Re: K973411

LD 2800 Film Digitizer Dated: September 8, 1997 Received: September 9, 1997 Unclassified/Procode: 90 LMA

Dear Mr. Leslie:

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 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 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 Ouality System Regulation (OS) 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 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 vitro 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,

hJliau 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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Page

K973411 510(k) Number (if known):__

Device Name: LD2800 (MARKET NAME)

DTG-MI Zoos (GSI INFERNAL

Indications For Use:

The General Scanning model LD2800 laser film digitizer is intended to create copies of medical images stored on film when connected to a laser imager. It is intended for use in making copies of conventional x-ray films as well as films produced by imagers that fall in the ranges specified for size and optical density range detailed in the specifications.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
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|--|--------------------------------------------------------|

| (Division Sign-Off) |
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| Division of Reproductive, Abdominal, ENT, and Radiological Devices |

| 510(k) Number | K973411 |
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| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
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