# K980809: Lumiscan 135 Phosphor Plate Digitizer/Lumisys 135 Eraser

- Pathway: 510(k) (Traditional)
- Applicant: Lumisys, Inc.
- Decided: May 11, 1998 after 69 days
- Product code: LMA (Digitizer, Image, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944046 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944046: Fuji Computed Radiography Systems, Fujifilm Medical System U.S.A., Inc. (1995) Summary page 1.
- (no number) Kodak, System 400 Reader: named in the summary without a submission number
- (no number) Agfa ADC Digitizer: named in the summary without a submission number

## 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-ray. 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.

Source page: https://510kreport.com/device/K980809
Methodology: https://510kreport.com/methodology