LD2000 SERIES

K980565 · General Scanning, Inc. · LMA · Mar 19, 1998 · Radiology

Device Facts

• Record ID: K980565
• Device Name: LD2000 SERIES
• Applicant: General Scanning, Inc.
• Product Code: LMA · Radiology
• Decision Date: Mar 19, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Indications for Use

The General Scanning model LD2000 SERIES laser film digitizer is intended to convert medical images stored on film to digital data for copying, storage, and transmission. It is intended for use to digitize copies of conventional x-rays and films produced by imagers that fall in the ranges for size and optical density range detailed in the specifications. The digitizer utilizes laser light to scan the film, extracts the image data by measuring the transmitted light, converts it into digital form, and transmits the data over a digital link. The digitized information may then be transmitted to a Laser Imager for printed hardcopy or to a Work Station for use in Teleradiology (transmission of images) or PACS (Picture Archiving Communication Systems). The LD2000 SERIES contains the scanning laser and detection module, a film transport, and electronics to convert and transmit the image data and provide control and calibration.

Device Story

LD2000 Series is a laser film digitizer; converts analog medical x-ray/film images into digital data. Input: physical film; process: focused laser beam scans film while motor-operated rollers transport film; transmitted light measured by nine solid-state photodiodes; A/D conversion creates digital pixel values. Output: digital image data transmitted via SCSI interface to workstations, PACS, or laser imagers. Used in clinical settings; operated by trained personnel. Benefits: enables teleradiology, digital storage, and electronic transmission of conventional film-based medical images.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through technical specifications including spatial resolution (up to 4096 x 4974 pixels), MTF (0.4 at 6 lp/mm), and optical density resolution.

Technological Characteristics

Laser film digitizer; visible semiconductor laser diode source; polygon scanner; nine solid-state photodiode detectors; 12-bit grey scale; SCSI interface. Dimensions: 11"D x 22.25"W x 40"H (with pedestal). Power: 87-132/200-264 VAC, 47-63 Hz. Firmware-controlled via PROM.

Indications for Use

Indicated for the digitization of conventional x-rays and medical films for copying, storage, and transmission in clinical environments. Applicable to films within specified size (8" to 14" wide) and optical density (0.03 to 3.5 OD) ranges. Prescription use only.

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

• General Scanning LD2800 (K973411)
• Lumiscan 85LF
• Lumiscan 100 (K901423)
• Konica (K9333830)
• Nishimoto Sangyo ED-2000
• Nishimoto Sangyo ED-3500

Submission Summary (Full Text)

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K980565

## MAR 1 9 1998

### 510(k) SUMMARY 2.

| 2.1 | Company Name | General Scanning Inc. (GSI)<br>500 Arsenal Street<br>Watertown, MA 02172 USA |
|-----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 2.2 | Contact Person | Steven P. Zis<br>Phone # [phone] x181<br>Fax # [phone] |
| 2.3 | Date | February 12, 1998 |
| 2.4 | Device Name | |
| | Classification Name | Medical Image Digitizer |
| | Classification Number | 90LMA - Radiology Device |
| | Common Name | Laser Film Digitizer |
| | Trade/Proprietary Name | LD2000 SERIES (Marketing Name) |
| 2.5 | Substantial Equivalence - Predicate Devices | |
| | General Scanning LD2800 | K973411 |
| | Lumiscan 85LF | |
| | Lumiscan 100 | K901423 |
| | Konica | K9333830 |
| | Nishimoto Sangyo ED-2000 | |
| | Nishimoto Sangyo ED-3500 | |
| 2.6 | Device Description and "Statement of Indications For Use"<br>The General Scanning model LD2000 SERIES laser film digitizer is<br>intended to convert medical images stored on film to digital data for<br>copying, storage, and transmission. It is intended for use to digitize copies<br>of conventional x-rays and films produced by imagers that fall in the<br>ranges for 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. The digitized information may then be | |

transmitted to a Laser Imager for printed hardcopy or to a Work Station for use in Teleradiology (transmission of images) or PACS (Picture Archiving Communication Systems).

The LD2000 SERIES contains the scanning laser and detection module, a film transport, and electronics to convert and transmit the image data and provide control and calibration.

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#### Principle of Operation - Overview 2.6.1

The digitizer is a system for converting images on x-ray and films into digital data. It accomplishes this by scanning a focused laser beam across the film as the film itself is moved by means of motor-operated rollers. Solid state photo diodes are used to detect the amount of laser light which passes through the film at each pixel. This provides a measure of optical density at each pixel, and this measurement becomes the digital value for that pixel. The aggregate of the digital values for all the pixels on the film being digitized is thus a digital representation of the film's image. The digitizer sends this digital version of the image via an electronic interface.

| MODULE | DESCRIPTION | MAIN COMPONENTS |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Laser | Supplies light beam of<br>appropriate size,<br>wavelength, and power to<br>the Scan. | Laser diode<br>Diode modulator board |
| Scan | Takes light beam from<br>Laser and scans it across<br>film in x-direction. | Spinning polygon w/built-<br>in controller<br>Lenses, mirrors |
| Transport | Detects and aligns film;<br>moves film through system. | Film sensor<br>Film rollers<br>Stepper motor |
| Light<br>Collection | Detects transmitted light;<br>performs A/D conversion. | Photodiodes<br>Diffusion screen<br>ADC board |
| Controller | Provides image data path;<br>generates pixel clock for<br>Light Collection; drives<br>stepper motor for Transport;<br>monitors sensors; controls<br>interface I/O. | Controller board |
| Software | Code for all Controller<br>functions. | PROM-based firmware |
| Power Supply | Provides electrical power<br>for all modules. +5 VDC for<br>digital circuits. ±5 and +<br>24VDC for analog circuits. | 5/24V linear supply<br>(2) 5V linear supplies |
| Enclosure | Provides light-tight, EMI-<br>ontrolled, clean<br>nvironment with reasonable<br>ser and service access. | Skins<br>Film input slot<br>Film exit bin<br>User interface<br>AC and data cables |

The table below describes and identifies the main components of the modules that make up the LD2000 SERIES digitizer.

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2.7

# LD2000 SERIES Specifications

| Light source | Visible semiconductor diode |
|-----------------------|-------------------------------------------------------------------------------------------------------------|
| Spot size | 85 - 170 µm |
| Image Detectors | |
| Type | Solid State |
| Quantity | Nine |
| Image Size | |
| Film Size: | 8" to 14" wide |
| Scan Size: | 14.0" x 17.0" min |
| Pixels Not On Film: | Set to Max OD value |
| Scan time (14" x 17") | 12 seconds typical for 2K resolution |
| Spatial Resolution | |
| Number of pixels: | 2048 x 2480<br>1024 x 1240<br>other pixel resolutions configurable up to<br>4096 x 4974 on a 14" x 17" film |
| Pixel Size: | ~170 µm @ 2048 pixels on 14"<br>~85 µm @ 4096 pixels on 14" |
| MTF @ 6 lp/mm: | 0.4 (85 µm pixel at 4096 pixels on 14") |
| Optical Density | |
| OD Range: | 0.03 to 3.5 |
| OD Resolution | OD .03 - 2.5: .01 OD<br>OD 2.5 - 3.0: .02 OD<br>OD 3.0 - 3.5: .05 OD |
| Interface | SCSI<br>(Custom Configurations available per Customer Specifications) |
| Grey scale resolution | 12 bits (4096) |
| Power requirements | |
| Voltage: | 87 - 132 / 200 - 264; 4 position user selected |
| Frequency: | 47 - 63 Hz Single Phase |
| Current Rating: | 650 mA |

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Temperature

operating non-operating 15C to 40C -40C to 60C

Relative Humidity operating non-operating

25-70% non-condensing 10-90%

Dimensions with pedestal wall mount

11"D x 22.25"W x 40" H 60 - 77 lbs. (with pedestal)

11"D x 22.25"W x 48.5" H

Weight

2.7

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| 2.8 | Substantial Equivalence Comparison and Chart<br>The General Scanning LD2000 SERIES is substantially equivalent to all<br>of the Lumisys, Nishimoto Sangyo and Konica digitizers listed.<br>Specifically, |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Size: | The General Scanning model LD2000 SERIES is slightly larger<br>in size than the other products listed. This is primarily due to a<br>stand which is offered with the product. |
| Weight: | General Scanning's product weight is 60 - 77 lbs. similar to the<br>Lumisys 85LF at 75 lbs. |
| Power: | All units offer dual voltage (120/240 VAC). |
| Scan size: | Maximum scan size for all listed digitizers is 14" x 17". |
| Spot size: | General Scanning's product has an 85um spot which falls<br>within the 50 - 420um spot offered by the Lumisys 100. |
| Density range: | Our density range of 0.03 - 3.5 OD is within the range offered<br>by all products listed. |
| Grey Scale: | All products listed except Konica offer 12 bit grey scale. |
| Laser source: | Konica and both Nishimoto Sangyo products use semi-<br>conductor laser sources. |
| Beam scan: | Konica and both Nishimoto Sangyo products use a polygon<br>scanner for scanning the x-axis of the image. |
| Maximum resolution: | General Scanning's product is exactly equal to the Nishimoto<br>Sangyo ED-3500, and is within the range offered in the<br>Lumisys 85LF. |
| Interface: | General Scanning is offering a standard SCSI or custom<br>interface. This is equivalent to the products listed. |

The following page show a chart highlighting the substantial equivalence of the LD2000 SERIES to the Lumiscan 85LF, Lumiscan100, Konica, Nishimoto Sangyo ED-2000 and ED-3500 Film Digitizer models.

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Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered on the image and is the only element present.

MAR 19 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Steven Zis Quality Systems Manager General Scanning, Inc. (GSI) Optical Scanning Products Division 500 Arsenal Street Watertown, MA 02172

Re:

K980565 LD2000 Series Dated: February 12, 1998 Received: February 13, 1998 Regulatory class: Unclassified Procode: 90 LMA

Dear Mr. Zis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we bare 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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drue, and Cosmetic Act (Act). You may, therefore, market the device, 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 problibitions 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 Felecal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Proctice requirements, as set forth in the Quality System Regulation (OS) 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 the Electronic Product 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 predication 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/dsmaldsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Statement of Indications for Use 1.1

The General Scanning model LD2000 SERIES laser film digitizer is intended to convert medical images stored on film to digital data for copying, storage, and transmission. It is intended for use to digitize copies of conventional x-rays and films produced by imagers that fall in the ranges for size and optical density range detailed in the specifications.

The digitizer utilizes laser light to scan the film, extracts the image data by measuring the transmitted light, converts it into digital form, and transmits the data over a digital link. The digitized information may then be transmitted to a Laser Imager for printed hardcopy or to a Work Station for use in Teleradiology (transmission of images) or PACS (Picture Archiving Communication Systems).

The LD2000 SERIES contains the scanning laser and detection module, a film transport, and electronics to convert and transmit the image data and provide control and calibration.

David A. Seymour
(Division Sign-Off)

Division of Reproductive, Abdominal, EN and Radiological De 510(k) Number

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