510(k) Report

510(k) · Cleared

Cleared

Dry Laser Imager, Model Drypro Model 793

K042133510(k) TraditionalCleared Nov 24, 2004107-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 Minolta Medical & Graphic, Inc. · LMC Camera, Multi Format, Radiological

Cleared on Nov 24, 2004 as substantially equivalent to K033821 (Eastman Kodak Company, 2004) after a 107-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.

Decided
Nov 24, 2004
Review
107 days
Class
Class II
Product code
LMC
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K002146 (2000). 2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2008: 1 descendant clearedK002146 · Kodak Dryview 8610 Laser Imager / for Mammography · Eastman Kodak Company · 2000K033821 · Kodak Dryview 8900 Laser Imager Mammography Accessory · Eastman Kodak Company · 2004200020052010201520202025
  1. Root · 2 generations backK002146 Kodak Dryview 8610 Laser Imager / for MammographyEastman Kodak Company · 2000
  2. 1 generation backK033821 Kodak Dryview 8900 Laser Imager Mammography AccessoryEastman Kodak Company · 2004
  3. This deviceK042133 Dry Laser Imager, Model Drypro Model 793Konica Minolta Medical & Graphic, Inc. · 2004
  4. Descendant · cites it directly · 0 of its ownK083522 Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009
  5. Descendant · cites it directly · 0 of its ownK081637 Laser Imager Drypro Model 873Konica Minolta Medical & Graphic, Inc. · 2008

Most influential descendants

Showing 2 of 2 · See all
  • K083522Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009 · cites it directly0descendants
  • K081637Laser Imager Drypro Model 873Konica Minolta Medical & Graphic, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K002146Kodak Dryview 8610 Laser Imager / for MammographyEastman Kodak Company2000—
−1K033821Kodak Dryview 8900 Laser Imager Mammography AccessoryEastman Kodak Company2004—
0 (this device)K042133Dry Laser Imager, Model Drypro Model 793Konica Minolta Medical & Graphic, Inc.2004—
+1K083522Sony UP-DF750 Digital Film ImagerSony Electronics, Inc.2009—
+1K081637Laser Imager Drypro Model 873Konica Minolta Medical & Graphic, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
FIG. 1 — Lineage of K042133, 2000–2009Source: 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 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? (1)

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
*K033821Kodak Dryview 8900 Laser Imager Mammography Accessory
Summary page 2
…e 2 === 9. Predicate Device The Dry Laser Imager, DRYPRO Model 793 is substantially equivalent to 1)RYVIEW 8900 manufactured by Eastman Kodak Company, 510(k) No.: K03382 1. Comparison of the principal characteristics of the two devices which are pertinent to Specification performance is attached…
Eastman Kodak Company2004—

Also cleared against K033821: 2 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K083522Sony UP-DF750 Digital Film ImagerSony Electronics, Inc.20090
K081637Laser Imager Drypro Model 873Konica Minolta Medical & Graphic, Inc.20080

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?

  • The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K083522 (Sony Electronics, Inc., 2009) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K033821.

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 Dry Laser Imager, DRYPRO Model 793 is intended to be used to acquire images from diagnostic equipment such as CT, MRI, DSA or FDA-approved Full Field Digital Mammography System and print the images on medical dry-film.

The devices are intended to be used by trained medical personnel in a clinic or hospital environment.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K042133: Dry Laser Imager, Model Drypro Model 793.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042133

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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