510(k) Report

510(k) · Cleared

Cleared

Fuji Computed Radiography (FCR) Clearview CS Image Reader

K042023510(k) TraditionalCleared Aug 25, 200428-day reviewClass II21 CFR 892.1680

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. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

Cleared on Aug 25, 2004 after a 28-day review. The FDA summary names its predicate without a number. 58 later devices descend from it.

Decided
Aug 25, 2004
Review
28 days
Class
Class II
Product code
MQB
Recalls
None
Predicates
0

58 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2007: 1 descendant cleared2011: 4 descendants cleared2012: 1 descendant cleared2013: 1 descendant cleared2014: 2 descendants cleared2022: 4 descendants cleared2016: 5 descendants cleared2017: 6 descendants cleared2019: 4 descendants cleared2020: 4 descendants cleared2015: 1 descendant cleared2024: 6 descendants cleared2025: 3 descendants cleared2018: 9 descendants cleared2021: 3 descendants cleared2026: 2 descendants cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK042023 Fuji Computed Radiography (FCR) Clearview CS Image ReaderFujifilm Medical System U.S.A., Inc. · 2004
  2. Descendant · cites it directly · 55 of its ownK100762 Flat Panel Detector, Model FDR D-EvoFujifilm Medical Systems U.S.A, Inc. · 2010
  3. Descendant · 2 generations on · 54 of its ownK103596 Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011
  4. Descendant · 3 generations on · 52 of its ownK111548 Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600…Fujifilm Medical System U.S.A., Inc. · 2011
  5. Descendant · 3 generations on · 50 of its ownK132509 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013
  6. Descendant · 4 generations on · 32 of its ownK141765 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2014

Showing 5 of 58 descendants. See all descendants

Descendants cleared per year

2007: 12010: 12011: 42012: 12013: 12014: 22015: 12016: 52017: 62018: 92019: 42020: 42021: 32022: 42023: 12024: 62025: 32026: 2
2007high 9 (2018) · low 0 (2008)2026

Most influential descendants

Showing 5 of 58 · See all
  • K100762Flat Panel Detector, Model FDR D-EvoFujifilm Medical Systems U.S.A, Inc. · 2010 · cites it directly55descendants
  • K103596Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011 · 2 generations on54descendants
  • K111548Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SEFujifilm Medical System U.S.A., Inc. · 2011 · 3 generations on52descendants
  • K132509FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013 · 3 generations on50descendants
  • K141765FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2014 · 4 generations on32descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K042023Fuji Computed Radiography (FCR) Clearview CS Image ReaderFujifilm Medical System U.S.A., Inc.2004—
+1K100762Flat Panel Detector, Model FDR D-EvoFujifilm Medical Systems U.S.A, Inc.2010—
+2K103596Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc.2011—
+3K111548Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SEFujifilm Medical System U.S.A., Inc.2011—
+3K132509FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc.2013—
+4K141765FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201010
201140
201210
201310
201420
201510
201650
201760
201890
201940
202040
202130
202240
202310
202460
202530
202620
FIG. 1 — Lineage of K042023, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 MQB? 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 MQB device

  1. #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 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? (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
*—FCR 9000HQ Image Reader
Named without a submission number
—
*—FCR 5501D Image Reader
Named without a submission number
—
*—FCR 9000 Image Reader
Named without a submission number
—

What descends from it? (58)

See all 58

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

NumberDeviceApplicantDecidedDescendants
K100762Flat Panel Detector, Model FDR D-EvoFujifilm Medical Systems U.S.A, Inc.201055
K071682Crystalview T-Series Computed Radiography System, Models T110 (with Eraser) and T100…Alara, Inc.20071

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, K100762 (Fujifilm Medical Systems U.S.A, Inc., 2010) has gone furthest, with 55 descendants of its own.

How does its category compare?

All MQB devices

MQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQB

8in 2025

2007: 132008: 82009: 152010: 112011: 242012: 222013: 212014: 322015: 212016: 222017: 312018: 162019: 222020: 192021: 212022: 312023: 102024: 82025: 82026 (partial year): 3
2007high 32 (2014) · low 8 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQB

127in 2025

2007: 22 days median2008: 15 days median2009: 57 days median2010: 116 days median2011: 102 days median2012: 80 days median2013: 105 days median2014: 102 days median2015: 81 days median2016: 92 days median2017: 30 days median2018: 30 days median2019: 30 days median2020: 28 days median2021: 48 days median2022: 48 days median2023: 30 days median2024: 187 days median2025: 127 days median2026 (partial year): 245 days median
2007high 245 (2026) · low 15 (2008)2026

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

Recalls per year · MQB

1in 2025

2007: 152008: 362009: 192010: 142011: 102012: 82013: 62017: 12018: 42019: 12020: 42021: 12025: 12026 (partial year): 1
2007high 36 (2008) · low 0 (2014)2026

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

Adverse event reports per year · MQB

141in 2025

2007: 252008: 302009: 342010: 392011: 1012012: 2672013: 1592014: 292015: 212016: 262017: 202018: 842019: 452020: 92021: 262022: 132023: 512024: 912025: 141
2007high 267 (2012) · low 9 (2020)2025

MAUDE reports naming product code MQB, 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
200713221525
20088153630
200915571934
2010111161439
20112410210101
201222808267
2013211056159
201432102029
20152181021
20162292026
20173130120
20181630484
20192230145
2020192849
20212148126
20223148013
20231030051
20248187091
202581271141
202632451—

What is it indicated for?

The indications for use of the Fuji Computed Radiography (FCR) ClearView CS image Reader with Image Plate (IP) reading is the identification, capture, digitization, and processing of diagnostic x-ray images of the human body, and associating patient and exam identification with the images.

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

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 MQB

The MQB category page

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https://510kreport.com/device/K042023 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042023: Fuji Computed Radiography (FCR) Clearview CS Image Reader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042023

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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