(69 days)
Not Found
No
The description focuses on the hardware and basic image digitization process, with no mention of AI, ML, or advanced image processing beyond simple scanning and data transfer.
No
The device is used for scanning medical radiographs and generating a digital signal from the transmitted light, which is an imaging and data acquisition function, not a therapeutic intervention.
No
This device is an image scanner that digitizes medical radiographs; it does not perform any diagnostic analysis or interpretation of the images.
No
The device description clearly states it is an "image scanner" with physical components like a laser beam, photomultiplier, and SCSI-2 interface, indicating it is a hardware device.
Based on the provided information, the Laser Film Digitizer 2905 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to scan medical radiographs (X-ray films) and generate a digital signal. This is a process of digitizing existing medical images, not performing a test on a biological sample to diagnose a condition.
- Device Description: The description focuses on the technical aspects of scanning and digitizing images from film. It doesn't mention any analysis of biological samples or chemical reactions.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device works with pre-existing images, not biological samples.
The device is a medical image processing device, specifically a digitizer for radiographic films.
N/A
Intended Use / Indications for Use
The Laser Film Digitizer is intended for reading black and white images from transmitted light through an X-ray film and the like and transferring the images as the digital data to a computer.
The Laser Film Digitizer 2905 is indicated for scanning medical radiographs with a laser beam and generating a digital electrical signal from the transmitted light.
Product codes (comma separated list FDA assigned to the subject device)
90 LMA
Device Description
The Laser Film Digitizer 2905 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images as the digital data to a computer. It has the following features:
- (1) Since the 2905 is equipped with a photomultiplier having wide dynamic range as a sensor, it can read high density films, such as a film whose optical density is up to 4.0.
- 2 The 2905 can output 4096 gray levels (12 bits) which are linear to optical density.
-
- The 2905 can read a film at high speed using laser.
- 4 The interface of the 2905 is SCSI-2, so that it can transfer data at high speed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Transmitted light through an X-ray film
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 1 5 1998
-
- Company Identification
Array Corporation 3-42-10 Yovogi, Shibuya-ku, Tokyo 151-0053 Japan Tel : +81-3-3320-3911 Fax : +81-3-3320-5918
- Company Identification
-
- Official Correspondent
Takashi Inami Manager Quality Engineering Dept.
- Official Correspondent
-
- Date of Submission
July 22, 1998
- Date of Submission
4. Device Trade name
2905
5. Common Name
Laser Film Digitizer
6. Classification
Medical image digitizers were reviewed by the Radiology Panel and are classified in Class II per 21 CFR 892.2030.
7. Predicate Device
Lumiscan 50, 510(k)# K933129, Lumiscan 20, 510(k)# K953964, manufactured by Lumisys Inc., 225 Humboldt Court, Sunnyvale, California 94089.
8. Description of Device
The Laser Film Digitizer 2905 is an image scanner which reads black and white images from transmitted light through an X-ray film and the like, and transfers the images as the digital data to a computer. It has the following features:
- (1) Since the 2905 is equipped with a photomultiplier having wide dynamic range as a sensor, it can read high density films, such as a film whose optical density is up to 4.0.
- 2 The 2905 can output 4096 gray levels (12 bits) which are linear to optical density.
-
- The 2905 can read a film at high speed using laser.
- 4 The interface of the 2905 is SCSI-2, so that it can transfer data at high speed.
1
9. Intended Use
The Laser Film Digitizer is intended for reading black and white images from transmitted light through an X-ray film and the like and transferring the images as the digital data to a computer.
10. Substantial Equivalence to Predicate Device
The 2905 is substantially equivalent to the Lumiscan 50 (K933129) and Lumiscan 20 (K953964), laser film digitizer manufactured by Lumisys Inc., 225 Humboldt Court, Sunnyvale, California Comparison of the principal characteristics of the three devices which are pertinent to 94089. clinical performance is shown below.
| Array | Lumisys | Lumisys | |
|---|---|---|---|
| Product Name | Model 2905 | Lumiscan 50 | Lumiscan 20 |
| 510(k) Number | ... | K933129 | K953964 |
| Dimensions | 526x766x330mm t | 21x13x27" | 21x13x27" |
| Weight | 45kg | 75lbs. | 75lbs. |
| Power (V ac/A/Hz) | 120/3/50-60 | 110/1/60 | 110/1/60 |
| Scan Size | 14x17" | 14x36" | 14x36" |
| Spot Size | 70μm | 210μm | 175μm |
| Dynamic Range | 0-4.0 OD | 0-4.1 OD | 0-3.8 OD |
| Gray Scale | 12 bits | 12 bits | 12 bits |
| Digitizing Rate | 300 lines/sec. | 115 lines/sec. | 160 lines/sec. |
| Laser | He-Ne Gas Laser | Laser | Solid State Array |
| Beam Scan | Polygonal Mirror | Galvanometer | CCD |
| Pixel per mm | 0.5-20 | 5 | 5.7 |
| Interface | SCSI | SCSI/PC ISA | SCSI/PC ISA |
11. Safety Concerns
The Laser Film Digitizer 2905 complies with the following standards (under application for Approvals).
UL1950 CAN/CSA-C22.2 No.950 TUV: EN 60950+A1+A2 EN 60825-1
Additionally, the Laser Film Digitizer 2905 complies with CFR 47, Part 15 and Radiation performance standards (21 CFR Chapter I, Sub-chapter J).
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, overlapping to create a sense of depth and connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 1998
Takashi Inami Manager, Qaulity Engineering Dept. Array Corporation 3-42-10 Yoyogi, Shibuya-Ku Tokyo 151-0053, Japan
Re:
- Laser Film Digitizer Dated: July 28, 1998 Received: August 7, 1998 Regulatory class: II 21 CFR 892.2030/Procode: 90 LMA
Dear Ms. Inami:
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 ensoment date of the Medical Device Amendments, or to 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 generals on 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 II (Special Controls) or 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 Fectiver one, Title 21, Parts 800 to 895. A substantially equivalent determines compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) 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 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 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 80) was additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-468. "Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliances 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/cdrf/dsmaldsmamain.html".
Sincerely yours,
William Yu
Lillian Yin. Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (If known): K982785
Device Name: Laser Film Digitizer 2905
Indications for Use:
The Laser Film Digitizer 2905 is indicated for scanning medical radiographs with a laser beam and generating a digital electrical signal from the transmitted light.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
David b. Syner
Division Sign-Off
(Division Sign-Off) Division Reproductive, Abdominal, EN and Radiological Devig 510(k) Number
Prescription Use X
OR Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)