510(k) Report

510(k) · Cleared

Cleared

Fuji Medical CR Console, Model Flash Iip

K041990510(k) TraditionalCleared Aug 6, 200414-day reviewClass II21 CFR 892.2050

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

Fujifilm Medical System U.S.A., Inc. · LLZ System, Image Processing, Radiological

Cleared on Aug 6, 2004 after a 14-day review. The FDA summary names its predicate without a number. 12 later devices descend from it.

Decided
Aug 6, 2004
Review
14 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

12 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2010: 1 descendant cleared2005: 2 descendants cleared2008: 2 descendants cleared2006: 1 descendant cleared2007: 1 descendant cleared2021: 1 descendant cleared2011: 1 descendant cleared2014: 1 descendant cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK041990 Fuji Medical CR Console, Model Flash IipFujifilm Medical System U.S.A., Inc. · 2004
  2. Descendant · cites it directly · 5 of its ownK051523 Regius Console CS-2000 and Regius Console CS-3000, Medical Image…Konica Minolta Medical & Graphic, Inc. · 2005 · Recalled
  3. Descendant · 2 generations on · 4 of its ownK071436 Regius UniteaKonica Minolta Medical & Graphic, Inc. · 2007 · Recalled
  4. Descendant · 3 generations on · 3 of its ownK101842 ACIESKonica Minolta Medical & Graphic, Inc. · 2011
  5. Descendant · 3 generations on · 2 of its ownK133730 CO Pilot/Regius UniteaKonica Minolta, Inc. · 2014
  6. Descendant · 3 generations on · 1 of its ownK210066 ImagePilotKonica Minolta, Inc. · 2021 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2005: 22006: 12007: 12008: 22010: 12011: 12014: 12017: 12021: 12024: 1
2005high 2 (2005) · low 0 (2009)2026

Most influential descendants

Showing 5 of 12 · See all
  • K051523Regius Console CS-2000 and Regius Console CS-3000, Medical Image Processing WorkstationKonica Minolta Medical & Graphic, Inc. · 2005 · cites it directly5descendants
  • K071436Regius UniteaKonica Minolta Medical & Graphic, Inc. · 2007 · 2 generations on4descendants
  • K101842ACIESKonica Minolta Medical & Graphic, Inc. · 2011 · 3 generations on3descendants
  • K133730CO Pilot/Regius UniteaKonica Minolta, Inc. · 2014 · 3 generations on2descendants
  • K210066ImagePilotKonica Minolta, Inc. · 2021 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K041990Fuji Medical CR Console, Model Flash IipFujifilm Medical System U.S.A., Inc.2004—
+1K051523Regius Console CS-2000 and Regius Console CS-3000, Medical Image Processing…Konica Minolta Medical & Graphic, Inc.20051
+2K071436Regius UniteaKonica Minolta Medical & Graphic, Inc.20071
+3K101842ACIESKonica Minolta Medical & Graphic, Inc.2011—
+3K133730CO Pilot/Regius UniteaKonica Minolta, Inc.2014—
+3K210066ImagePilotKonica Minolta, Inc.20211

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200610
200710
200820
201010
201110
201410
201710
202110
202410
FIG. 1 — Lineage of K041990, 2004–2024Source: 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 LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LLZ device

  1. #1 K230955 syngo Application Softwarescore 21.6 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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
*—Fuji CR DIMS CRT Image Console HI-C654
Named without a submission number
—

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K051523Regius Console CS-2000 and Regius Console CS-3000, Medical Image Processing WorkstationKonica Minolta Medical & Graphic, Inc.20055
K051521Regius RS-1000, Medical Image Processing WorkstationKonica Minolta Medical & Graphic, Inc.20051
K170451FDX Console (DR-ID300CL) SoftwareFujifilm Medical Systems U.S.A, Inc.20170
K091631Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc.20100
K081308Fujifilm FCR View, Model CR-VW674Fujifilm Medical Systems U.S.A, Inc.20080
K073650Fujifilm Unity Speedsuite, Model CR-IR 371Fujifilm Medical Systems U.S.A, 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?

  • Of its descendants, K051523 (Konica Minolta Medical & Graphic, Inc., 2005) has gone furthest, with 5 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

The Fuji CR Console is a CR modality workstation intended to associate FCR images (except mammography images) with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.

Indications for use as stated in the FDA summary.

More from Fujifilm Medical System U.S.A., Inc.

74 FDA decisions under this applicant name. See the company

  • K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017
  • K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc. · 2016
  • K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc. · 2016
  • K152138FDR D-EVO GL Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc. · 2015
  • K150221EPX-4440HD and EPX-4400HD with FICEFujifilm Medical System U.S.A., Inc. · 2015

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K041990 · printed Nov 3, 2026

Cite this page

510(k) Report. “K041990: Fuji Medical CR Console, Model Flash Iip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K041990

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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