510(k) Report

510(k) · Cleared

Cleared

Konica Laser Imager, Model Drypro Model 771

K032681510(k) SpecialCleared Sep 24, 200326-day reviewClass II21 CFR 892.2040

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

Konica Medical and Graphic Corporation · LMC Camera, Multi Format, Radiological

Cleared on Sep 24, 2003 after a 26-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided
Sep 24, 2003
Review
26 days
Class
Class II
Product code
LMC
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared200020052010201520202025
  1. This deviceK032681 Konica Laser Imager, Model Drypro Model 771Konica Medical and Graphic Corporation · 2003
  2. Descendant · cites it directly · 0 of its ownK061999 Dry Laser Imager, Drypro Model 832Konica Minolta Medical & Graphic, Inc. · 2006

Most influential descendants

Showing 1 of 1 · See all
  • K061999Dry Laser Imager, Drypro Model 832Konica Minolta Medical & Graphic, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K032681Konica Laser Imager, Model Drypro Model 771Konica Medical and Graphic Corporation2003—
+1K061999Dry Laser Imager, Drypro Model 832Konica Minolta Medical & Graphic, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K032681, 2003–2006Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LMC? 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061999Dry Laser Imager, Drypro Model 832Konica Minolta Medical & Graphic, Inc.20060

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?

  • Of its descendants, K061999 (Konica Minolta Medical & Graphic, Inc., 2006) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LMC devices

LMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMC

2in 2014

2007: 12008: 12009: 32011: 12014: 2
2007high 3 (2009) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LMC

80in 2009

2009: 80 days median
2007high 80 (2009)2026

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

Recalls per year · LMC

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · LMC

2in 2018

2013: 12014: 12018: 2
2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code LMC, 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
20071—00
20081—10
200938000
20100—00
20111—00
20120—00
20130—01
20142—01
20150—00
20160—00
20170—00
20180—02
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Konica Laser Imager DRYPRO model 771 is a laser imager converts data from diagnostic equipment such as CT, MRI, DSA, and other medical devices into various intensities, scan and then print the data onto laser imaging film.

Indications for use as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K032681: Konica Laser Imager, Model Drypro Model 771.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032681

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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