(69 days)
No
The description focuses on the physical process of digitizing and erasing phosphor plates using lasers and optics, with no mention of AI or ML algorithms for image processing or analysis. The "processing and manipulation" mentioned is likely standard digital image processing, not AI/ML.
No
The device is described as a laser phosphor plate digitizer that reads recorded patient radiation patterns and prepares plates for re-use, primarily for diagnostic imaging purposes (X-ray image acquisition and processing), not for treating a condition or disease.
No.
The LUMISCAN 135 system is a digitizer that reads recorded patient radiation patterns from a plate to provide an image. It does not perform any diagnostic function on the image itself, but rather provides the raw data for diagnostic interpretation by a physician or technologist.
No
The device description clearly outlines significant hardware components including a laser, plate transport system, optics module, reading electronics, and an eraser unit with lamps. While it mentions image processing, the core functionality relies on physical interaction with a phosphor plate and hardware for scanning and erasing.
Based on the provided information, the LUMISCAN 135 system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- LUMISCAN 135 Function: The LUMISCAN 135 system is designed to read and digitize radiation patterns recorded on a phosphor plate after a patient has been exposed to X-rays. It processes the physical information stored on the plate, not biological specimens.
- Intended Use: The intended use clearly states it reads "recorded patient radiation patterns" and prepares the plate for re-use. This is related to medical imaging, specifically computed radiography, which is a form of diagnostic imaging, but not an in vitro diagnostic process.
The device is a component of a medical imaging system used for diagnostic purposes, but it does not perform tests on biological samples.
N/A
Intended Use / Indications for Use
The LUMISCAN 135 system is a laser phosphor plate digitizer designed for darkroom operation to read recorded patient radiation patterns in the plate and a plate eraser system to prepare the plate for re-use. The system is based on a fixed size scanning spot and is characterized by high spatial resolution and a wide gray scale dynamic range. This is achieved with a high intensity spot of light derived from a solid-state laser that is scanned across the plate as the plate is moved perpendicular to the beam scan. As the laser scans the plate, the phosphor's stored x-ray attenuated equivalent energy is released as a different light wavelength. The emitted light is collected and digitized to provide an image that can be stored on disk, transmitted to other systems for processing and manipulation, archived or printed onto film. After the plate has been read, it is placed on a high intensity sealed lightbox for erasure. Erasing the plate brings all the phosphors down to a ground state from which the plate is now ready to be reused to record a patient's anatomy from x-rav.
The LUMISCAN 135 houses a plate transport system, optics module and reading electronics. Separate from the LUMISCAN 135 is the eraser unit, Lumisys 135E, which incorporates high intensity lamps with a light-tight lid for returning the phosphors to zero.
Product codes
90 LMA
Device Description
The LUMISCAN 135 system is a laser phosphor plate digitizer designed for darkroom operation to read recorded patient radiation patterns in the plate and a plate eraser system to prepare the plate for re-use. The system is based on a fixed size scanning spot and is characterized by high spatial resolution and a wide gray scale dynamic range. This is achieved with a high intensity spot of light derived from a solid-state laser that is scanned across the plate as the plate is moved perpendicular to the beam scan. As the laser scans the plate, the phosphor's stored x-ray attenuated equivalent energy is released as a different light wavelength. The emitted light is collected and digitized to provide an image that can be stored on disk, transmitted to other systems for processing and manipulation, archived or printed onto film. After the plate has been read, it is placed on a high intensity sealed lightbox for erasure. Erasing the plate brings all the phosphors down to a ground state from which the plate is now ready to be reused to record a patient's anatomy from x-rav.
The LUMISCAN 135 houses a plate transport system, optics module and reading electronics. Separate from the LUMISCAN 135 is the eraser unit, Lumisys 135E, which incorporates high intensity lamps with a light-tight lid for returning the phosphors to zero.
The LUMISCAN 135 uses a solid state laser diode as the beam source. The laser is conditioned by a lens for beam forming and coupled to a fiber. From the fiber, the energy is directed to a scanning galvanometer. The galvanometer has a mirror that is oscillating precisely across the width of the plate and irradiating the plate with laser light. As the light impinges the plate, stored energy from the plate is emitted and collected in an integrating cylinder. The collected light is detected by a photomultiplier, converted to an analog signal which is logarithmically amplified, corrected for spatial variations in the integrating cylinder, and then digitized by an A/D converter.
Mentions image processing
The emitted light is collected and digitized to provide an image that can be stored on disk, transmitted to other systems for processing and manipulation, archived or printed onto film.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
patient's anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician or technologist
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)
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
MAY | | 1998
510(k) Summary
1. Company Identification
Lumisys Inc. 225 Humboldt Court Sunnyvale, CA 94089 Tel. (408) 733-6565 Fax (408) 733-6567
2. Official Correspondent
Garv J. Allsebrook Requlatory Affairs
3. Date of Submission
February 28, 1998
4. Device Name
| Classification Name: | Image Digitizer |
|---|---|
| Common/Usual Name: | Phosphor Plate Digitizer |
| Proprietary Name: | Lumiscan 135 Phosphor Plate Digitizer (PPD) |
5. Substantial Equivalence
Fuii, Computed Radiography FCR AC-3, K944046; Kodak, System 400 Reader, 510(k) # Not Known, Agfa ADC Digitizer, 510(k) # Not Known
6. Device Description and Intended Use
The LUMISCAN 135 system is a laser phosphor plate digitizer designed for darkroom operation to read recorded patient radiation patterns in the plate and a plate eraser system to prepare the plate for re-use. The system is based on a fixed size scanning spot and is characterized by high spatial resolution and a wide gray scale dynamic range. This is achieved with a high intensity spot of light derived from a solid-state laser that is scanned across the plate as the plate is moved perpendicular to the beam scan. As the laser scans the plate, the phosphor's stored x-ray attenuated equivalent energy is released as a different light wavelength. The emitted light is collected and
1980800
1
digitized to provide an image that can be stored on disk, transmitted to other systems for processing and manipulation, archived or printed onto film. After the plate has been read, it is placed on a high intensity sealed lightbox for erasure. Erasing the plate brings all the phosphors down to a ground state from which the plate is now ready to be reused to record a patient's anatomy from x-rav.
The LUMISCAN 135 houses a plate transport system, optics module and reading electronics. Separate from the LUMISCAN 135 is the eraser unit, Lumisys 135E, which incorporates high intensity lamps with a light-tight lid for returning the phosphors to zero.
The LUMISCAN 135 uses a solid state laser diode as the beam source. The laser is conditioned by a lens for beam forming and coupled to a fiber. From the fiber, the energy is directed to a scanning galvanometer. The galvanometer has a mirror that is oscillating precisely across the width of the plate and irradiating the plate with laser light. As the light impinges the plate, stored energy from the plate is emitted and collected in an integrating cylinder. The collected light is detected by a photomultiplier, converted to an analog signal which is logarithmically amplified, corrected for spatial variations in the integrating cylinder, and then digitized by an A/D converter.
7. Hazard Analysis
Potential hazards as a result of equipment malfunction are:
-
- Phosphor plate may not digitize
-
- Phosphor plate may digitize partially.
-
- Image artifacts, and
-
- Phosphor plate may not completely erase.
The software has been designed to provide a user with system messages in case of equipment malfunction. These messages are listed in the Operators' Reference Guide and include a probable cause with any recommended action(s). Any artifacts that may be introduced into a digitized image, such as vertical lines resulting from dirt on the optics, are obvious to a physician or technologist.
2
8. Safety Concerns
The hardware complies with one or more of the following safety standards (or the most current revision at the time of testing):
UL 1950 CAN/CSA-C22.2 No. 950-93 TUV: EN 60950/08.92 EN 60950 A1/01.93 EN 60950 A2/08.93 EN 60825-1/03.94
Additionally, the hardware complies with CFR 47, Part 15 and DHHS Additionally, the marawards (21 CFR Subchapter J) as appropriate.
Substantial Equivalence 9.0
| Lumisys | Fuji | Kodak | Agfa | |
|---|---|---|---|---|
| Product Name | Lumiscan 135 | Fuji FCR | ||
| AC-3 | System 400 | |||
| Reader | ADC | |||
| Digitizer | ||||
| 510(k) Number | K944046 | Not Known | Not Known | |
| Dimensions | ||||
| (WxHxD) (cm) | 53x33x69 | 71x105x68 | 108x141x101 | 165x180x180 |
| Weight (kg) | 165 | 180 | 270 | 500 |
| Power (VAC/A/Hz) | 120/2/60 or | |||
| 220/1/50 | 120/2/60 | 120/2/60 | ||
| 220/1/50 | 220/14/60 | |||
| Scan Size (max) | ||||
| (WxL) (cm) | 35 x 43 | 35 x 43 | 35 x 43 | 35 x 43 |
| Spot Size (microns) | 100 | Not Known | 100 | 120 |
| Dynamic Range | 5 Decades | Not Known | Not Known | Not Known |
| Gray Scale | 12 Bit | 10 Bit | 12 Bit | 12 Bit |
| Digitizing Rate | 60 per hour | 70 per hour | 50 | 70 per hour |
| Laser | 30 mW | |||
| Solid State | Not Known | 30 mW | ||
| HeNe | 35 mW | |||
| HeNe | ||||
| Beam Scan | Galvanometer | Polygonal | ||
| Mirror | Galvanometer | Galvanometer | ||
| Resolution X/Y | 2.85 - 5 | |||
| LP/mm | Not Known | Not Known | 3-4.5 | |
| LP/mm | ||||
| Pixels per mm (35 x 43) | 5-10 | 5-10 | Not Known | Not Known |
| Interface | PC, ISA or | |||
| SCSI | Proprietary | Proprietary | Proprietary |
The following products provide functions, which are substantially equivalent to this product:
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY | |-1998
c/o Regulatory Management Services
Lumisys, Inc.
Gary J. Allsebrook
Official Correspondent
16303 Panoramic Way
San Leandro, CA 94578
Re:
K980809 Lumiscan 135 Phosphor Plate Digitizer Lumiscan 135E Eraser Dated: February 28, 1998 Received: March 3, 1998 Regulatory class: Unclassified Procode: 90 LMA
Dear Mr. Allsebrook:
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 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, narket 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 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 Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 submission does not affect any obligation you might have under sections 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 vitto 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/odrb/dsmaldsmam.html".
Sincerely yours,
Kilian Yin
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
4
Page 1 of 1
510(k) Number (if known):
Lumiscan 135 Phosphor Plate Digitizer (PPD) and Lumisys Device Name: 135E Eraser.
Indications For Use:
The LUMISCAN 135 system is a laser phosphor plate digitizer designed for darkroom operation to read recorded patient radiation patterns in the plate and a plate eraser system to prepare the plate for re-use. The system is based on a fixed size scanning spot and is characterized by high spatial resolution and a wide gray scale dynamic range. This is achieved with a high intensity spot of light derived from a solid-state laser that is scanned across the plate as the plate is moved perpendicular to the beam scan. As the laser scans the plate, the phosphor's stored x-ray attenuated equivalent energy is released as a different light wavelength. The emitted light is collected and digitized to provide an image that can be stored on disk, transmitted to other systems for processing and manipulation, archived or printed onto film. After the plate has been read, it is placed on a high intensity sealed lightbox for erasure. Erasing the plate brings all the phosphors down to a ground state from which the plate is now ready to be reused to record a patient's anatomy from x-rav.
The LUMISCAN 135 houses a plate transport system, optics module and reading electronics. Separate from the LUMISCAN 135 is the eraser unit, Lumisys 135E, which incorporates high intensity lamps with a light-tight lid for returning the phosphors to zero.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 901.109)
OR
Over-the-Counter Use
John H. Seym
Division Sign Off
Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological Devi
510(k) Number
(Optional Format 1-2-96)