(34 days)
Not Found
No
The description focuses on the physical process of scanning film with a laser and converting the light transmission to digital data. There is no mention of algorithms that learn or adapt from data.
No.
The device converts medical images stored on film to digital data for storage, copying, and transmission. It does not provide any therapeutic benefit to a patient.
No
Explanation: The device is described as a film digitizer, which converts existing medical images from film to digital data. Its stated purpose is for copying, storage, and transmission, not for generating new diagnostic information or interpreting images.
No
The device description explicitly states that the LD2000 SERIES contains hardware components such as a scanning laser and detection module, a film transport, and electronics. It is a physical device that converts film to digital data, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to convert medical images stored on film (conventional x-rays and films from imagers) into digital data for copying, storage, and transmission. This process is focused on handling existing medical images, not on analyzing biological samples or providing diagnostic information directly from a biological source.
- Device Description: The device description details the process of scanning film with a laser to measure optical density and convert it to digital data. This is a process of digitizing an image, not performing a diagnostic test on a biological specimen.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on the analysis of such samples.
The device is a tool for managing and transmitting existing medical images, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
90LMA
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
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.
0
MAR 1 9 1998
510(k) SUMMARY 2.
| 2.1 | Company Name | General Scanning Inc. (GSI)
500 Arsenal Street
Watertown, MA 02172 USA |
|-----|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 2.2 | Contact Person | Steven P. Zis
Phone # (617) 924-1010 x181
Fax # (617) 923-1877 |
| 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"
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.
1
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 | |
| appropriate size, | ||
| wavelength, and power to | ||
| the Scan. | Laser diode | |
| Diode modulator board | ||
| Scan | Takes light beam from | |
| Laser and scans it across | ||
| film in x-direction. | Spinning polygon w/built- | |
| in controller | ||
| Lenses, mirrors | ||
| Transport | Detects and aligns film; | |
| moves film through system. | Film sensor | |
| Film rollers | ||
| Stepper motor | ||
| Light | ||
| Collection | Detects transmitted light; | |
| performs A/D conversion. | Photodiodes | |
| Diffusion screen | ||
| ADC board | ||
| Controller | Provides image data path; | |
| generates pixel clock for | ||
| Light Collection; drives | ||
| stepper motor for Transport; | ||
| monitors sensors; controls | ||
| interface I/O. | Controller board | |
| Software | Code for all Controller | |
| functions. | PROM-based firmware | |
| Power Supply | Provides electrical power | |
| for all modules. +5 VDC for | ||
| digital circuits. ±5 and + | ||
| 24VDC for analog circuits. | 5/24V linear supply | |
| (2) 5V linear supplies | ||
| Enclosure | Provides light-tight, EMI- | |
| ontrolled, clean | ||
| nvironment with reasonable | ||
| ser and service access. | Skins | |
| Film input slot | ||
| Film exit bin | ||
| User interface | ||
| AC and data cables |
The table below describes and identifies the main components of the modules that make up the LD2000 SERIES digitizer.
2
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 |
| 1024 x 1240 | |
| other pixel resolutions configurable up to | |
| 4096 x 4974 on a 14" x 17" film | |
| Pixel Size: | ~170 µm @ 2048 pixels on 14" |
| ~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 |
| OD 2.5 - 3.0: .02 OD | |
| OD 3.0 - 3.5: .05 OD | |
| Interface | SCSI |
| (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 |
3
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
4
| 2.8 | Substantial Equivalence Comparison and Chart
The General Scanning LD2000 SERIES is substantially equivalent to all
of the Lumisys, Nishimoto Sangyo and Konica digitizers listed.
Specifically, |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Size: | The General Scanning model LD2000 SERIES is slightly larger
in size than the other products listed. This is primarily due to a
stand which is offered with the product. |
| Weight: | General Scanning's product weight is 60 - 77 lbs. similar to the
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
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
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-
conductor laser sources. |
| Beam scan: | Konica and both Nishimoto Sangyo products use a polygon
scanner for scanning the x-axis of the image. |
| Maximum resolution: | General Scanning's product is exactly equal to the Nishimoto
Sangyo ED-3500, and is within the range offered in the
Lumisys 85LF. |
| Interface: | General Scanning is offering a standard SCSI or custom
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.
5
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
6
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) ✓