(86 days)
K901423, K9337830
Not Found
No
The description focuses on the physical process of scanning and digitizing film using laser technology and standard electronics, with no mention of AI or ML algorithms for image analysis, interpretation, or processing beyond basic data conversion and transmission.
No
The device is a laser film digitizer used to create copies of medical images from film, not to diagnose, treat, or prevent a disease or condition.
No.
The device is described as a "laser film digitizer" intended "to create copies of medical images stored on film when connected to a laser imager." It extracts image data and converts it into digital form for transmission or printing, but it does not analyze or interpret the images to diagnose medical conditions.
No
The device description explicitly states it contains hardware components such as a scanning laser, detection module, film transport, and electronics.
Based on the provided information, the General Scanning model LD2800 laser film digitizer is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to create copies of medical images stored on film. This is a process of duplicating existing images, not analyzing biological samples or providing diagnostic information directly from a biological source.
- Device Description: The device digitizes existing film images. It doesn't interact with biological specimens or perform tests on them.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on analysis of biological samples.
The device is a tool for handling and reproducing medical images, which falls under the category of medical imaging equipment, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
90LMA
Device Description
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.
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. A laser imager may then be used to print a copy of the original image.
The LD2800 contains the scanning laser and detection module, a film transport, and electronics to convert and transmit the image data and provide control and calibration.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray films
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K901423, K9337830
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
510(k) SUMMARY 2.
f
| 2.1 | Company Name | General Scanning Inc. (GSI)
500 Arsenal Street
Watertown, MA 02172 USA | |
|-----|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------|
| 2.2 | Contact Person | Walter J. Leslie
Phone # (617) 924-1010 x197
Fax # (617) 926-0708 | |
| 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)
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"
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.
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. A laser imager may then be used to print a
copy of the original image.
The LD2800 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
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 (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/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
2
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K973411 |
|---|---|
| --------------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)