510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Carestream DRX-1 System

K090318510(k) TraditionalCleared Apr 6, 200956-day reviewClass II21 CFR 892.1680Recalls 2

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

Carestream Health, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)

Cleared on Apr 6, 2009 as substantially equivalent to K020635 (Eastman Kodak Company, 2002) after a 56-day review. Its family tree reaches back 1 generation to 2002. 79 later devices descend from it. It has been recalled 2 times.

Decided
Apr 6, 2009
Review
56 days
Class
Class II
Product code
MQB
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K020635 (2002). 79 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2013: 3 descendants cleared2010: 1 descendant cleared2015: 4 descendants cleared2012: 1 descendant cleared2011: 3 descendants cleared2016: 7 descendants cleared2019: 9 descendants cleared2020: 6 descendants cleared2014: 2 descendants cleared2022: 5 descendants cleared2026: 3 descendants cleared2017: 7 descendants cleared2018: 9 descendants cleared2023: 3 descendants cleared2025: 5 descendants cleared2024: 7 descendants cleared2021: 3 descendants clearedK020635 · Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview CR 900 System, Catalog# 1170976 · Eastman Kodak Company · 2002 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 11 descendants4 generations forward: 10 descendants5 generations forward: 19 descendants6 generations forward: 18 descendants7 generations forward: 4 descendants8 generations forward: 3 descendants9 generations forward: 3 descendants10 generations forward: 3 descendants K020635 · Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview CR 900 System, Catalog# 1170976 · Eastman Kodak Company · 2002 · recalled0+5+10
  1. Root · 1 generation backK020635 Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview…Eastman Kodak Company · 2002 · Recalled
  2. This deviceK090318 Carestream DRX-1 SystemCarestream Health, Inc. · 2009
  3. Descendant · cites it directly · 55 of its ownK100762 Flat Panel Detector, Model FDR D-EvoFujifilm Medical Systems U.S.A, Inc. · 2010
  4. Descendant · 2 generations on · 54 of its ownK103596 Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011
  5. 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
  6. Descendant · 3 generations on · 50 of its ownK132509 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013
  7. 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 79 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 32012: 12013: 32014: 22015: 42016: 72017: 72018: 92019: 92020: 62021: 32022: 52023: 32024: 72025: 52026: 3
2009high 9 (2018) · low 1 (2009)2026

Most influential descendants

Showing 5 of 79 · 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
−1K020635Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview CR 900…Eastman Kodak Company20021
0 (this device)K090318Carestream DRX-1 SystemCarestream Health, Inc.2009—
+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
200910
201010
201130
201210
201330
201420
201540
201670
201770
201890
201990
202060
202130
202250
202330
202470
202550
202630
FIG. 1 — Lineage of K090318, 2002–2026Source: 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 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? (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
*K020635Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview CR 900 System…
Summary page 1
…repared: February 6, 2009 Device Name: Carestream DRX-1 System 21 CFR 892.1650 MQB Equivalent Device (currently marketed): Kodak DirectView CR 850 System, 510k number: K020635 Device Description: The Carestream DRX-1 System is a digital imaging system to be used with diagnostic x-ray systems. It include…
Eastman Kodak Company20021

Also cleared against K020635: 1 other device →

What descends from it? (79)

See all 79

4 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
K091889DRX-Evolution, Model VX3733-SysCarestream Health, Inc.200930
K130464Carestream DRX-1 System with DRX 2530C DetectorCarestream Health, Inc.201317
K122726Cpi Rad VisionCommunications & Power Industries Canada, Inc.20130

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 29, 2013Class IIZ-0180-2014Software designCarestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6…
Jun 12, 2012Class IIZ-2202-2012Nonconforming Material/ComponentCarestream DRX-1 System batteries manufactured before June 2012 due to two occurrences of lithium-ion battery overheating, which may cause burns.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K100762 (Fujifilm Medical Systems U.S.A, Inc., 2010) has gone furthest, with 55 descendants of its own.
  • 1 other device also cites its predicate K020635.

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. 2009, this device’s year, is highlighted.

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 Carestream DRX-1 System is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. Excluded from the indications for use are mammography, fluoroscopy, tomography and angiography applications.

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 K020635

1 other device cites the same predicate.

  • K071546EOSBiospace Med · 20071 recall

More from Carestream Health, Inc.

53 FDA decisions under this applicant name. See the company

  • K251168Image SuiteCarestream Health, Inc. · 2025
  • K241505DRX-Revolution Mobile X-ray SystemCarestream Health, Inc. · 2024
  • K233381DRX-Evolution Plus SystemCarestream Health, Inc. · 2024
  • K223842DRX - CompassCarestream Health, Inc. · 2023
  • K213307Eclipse II with Smart Noise CancellationCarestream Health, Inc. · 2022

Recent decisions in MQB

The MQB category page

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  • K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) Limited · 2025
  • K250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp. · 2025

https://510kreport.com/device/K090318 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090318: Carestream DRX-1 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090318

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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