510(k) Report

510(k) · Cleared

Cleared

Lumiscan 135 Phosphor Plate Digitizer/Lumisys 135 Eraser

K980809510(k) TraditionalCleared May 11, 199869-day reviewClass II21 CFR 892.2030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lumisys, Inc. · LMA Digitizer, Image, Radiological

Cleared on May 11, 1998 as substantially equivalent to K944046 (Fujifilm Medical System U.S.A., Inc., 1995) after a 69-day review. Its family tree reaches back 1 generation to 1995.

Decided
May 11, 1998
Review
69 days
Class
Class II
Product code
LMA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K944046 (1995). No later device cites it as a predicate yet.

K944046 · Fuji Computed Radiography Systems · Fujifilm Medical System U.S.A., Inc. · 1995 · recalled199619982000
K944046 · Fuji Computed Radiography Systems · Fujifilm Medical System U.S.A., Inc. · 1995 · recalled0
  1. Root · 1 generation backK944046 Fuji Computed Radiography SystemsFujifilm Medical System U.S.A., Inc. · 1995 · Recalled
  2. This deviceK980809 Lumiscan 135 Phosphor Plate Digitizer/Lumisys 135 EraserLumisys, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944046Fuji Computed Radiography SystemsFujifilm Medical System U.S.A., Inc.19951
0 (this device)K980809Lumiscan 135 Phosphor Plate Digitizer/Lumisys 135 EraserLumisys, Inc.1998—
FIG. 1 — Lineage of K980809, 1995–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LMA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K944046Fuji Computed Radiography Systems
Summary page 1
…ommon/Usual Name: Phosphor Plate Digitizer Proprietary Name: Lumiscan 135 Phosphor Plate Digitizer (PPD) . Substantial Equivalence Fuji, Computed Radiography FCR AC-3, K944046; Kodak, System 400 Reader, 510(k) # Not Known, Agfa ADC Digitizer, 510(k) # Not Known . Device Description and Intended Use The…
Fujifilm Medical System U.S.A., Inc.19951
*—Kodak, System 400 Reader
Named without a submission number
—
*—Agfa ADC Digitizer
Named without a submission number
—

Also cleared against K944046: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • 1 other device also cites its predicate K944046.

How does its category compare?

All LMA devices

LMA Digitizer, Image, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMA

3in 2013

2009: 12010: 22013: 3
2007high 3 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LMA

80in 2013

2013: 80 days median
2007high 80 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LMA

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LMA

1in 2013

2008: 32012: 12013: 1
2007high 3 (2008) · low 0 (2007)2025

MAUDE reports naming product code LMA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—03
20091—00
20102—00
20110—00
20120—01
201338001
20140—00
20150—00
20160—00
20170—00
20180—00
20190—10
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

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…

Read the full statement (224 words)

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K944046

1 other device cites the same predicate.

  • K993861Fuji Computed Radiography Dual Side Reading, Both Side Reading, FCR 5501D Dual Side ReaderFujifilm Medical System U.S.A., Inc. · 20001 recall

More from Lumisys, Inc.

7 FDA decisions under this applicant name. See the company

  • K980213DI-2000Lumisys, Inc. · 1998
  • K953371Lumisys Dicom TooklitLumisys, Inc. · 1995
  • K953964Lumisys, Lumiscan 20Lumisys, Inc. · 1995
  • K933129Lumiscan 50Lumisys, Inc. · 1993
  • K902347Compact Laser Imager, Model Cli-100Lumisys, Inc. · 1991

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https://510kreport.com/device/K980809 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980809: Lumiscan 135 Phosphor Plate Digitizer/Lumisys 135 Eraser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980809

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026