510(k) · Cleared
Recalled · Class II · 2014Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview CR 900 System, Catalog# 1170976
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eastman Kodak Company · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Mar 21, 2002 after a 22-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 88 later devices descend from it. It has been recalled once.
- Decided
- Mar 21, 2002
- Review
- 22 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 1
- Predicates
- 1
88 later devices descend from it, 2 citing it directly.
- This deviceK020635 Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview…Eastman Kodak Company · 2002
- Descendant · cites it directly · 79 of its ownK090318 Carestream DRX-1 SystemCarestream Health, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 55 of its ownK100762 Flat Panel Detector, Model FDR D-EvoFujifilm Medical Systems U.S.A, Inc. · 2010
- Descendant · 3 generations on · 54 of its ownK103596 Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011
- Descendant · 4 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
- Descendant · 4 generations on · 50 of its ownK132509 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · See all- K090318Carestream DRX-1 SystemCarestream Health, Inc. · 2009 · cites it directly79descendants
- K100762Flat Panel Detector, Model FDR D-EvoFujifilm Medical Systems U.S.A, Inc. · 2010 · 2 generations on55descendants
- K103596Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011 · 3 generations on54descendants
- K111548Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SEFujifilm Medical System U.S.A., Inc. · 2011 · 4 generations on52descendants
- K132509FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013 · 4 generations on50descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020635 | Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview CR 900… | Eastman Kodak Company | 2002 | — |
| +1 | K090318 | Carestream DRX-1 System | Carestream Health, Inc. | 2009 | 2 |
| +2 | K100762 | Flat Panel Detector, Model FDR D-Evo | Fujifilm Medical Systems U.S.A, Inc. | 2010 | — |
| +3 | K103596 | Wireless/Wired FDR D-Evo Flat Panel Detector | Fujifilm Medical Systems U.S.A, Inc. | 2011 | — |
| +4 | K111548 | Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SE | Fujifilm Medical System U.S.A., Inc. | 2011 | — |
| +4 | K132509 | FDR D-Evo Flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 7 | 0 |
| 2018 | 9 | 0 |
| 2019 | 10 | 0 |
| 2020 | 7 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 8 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 0 |
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 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K923544 | FDA’s K923544 is One Touch Test Strips Our OCR of the scanned summary read K923544, FDA’s number for One Touch Test Strips (Lifescan, Inc.), which shares no applicant, product code or review panel with this device, and the summary gives no name to check it against. Kept off the family tree. Summary page 2…not clinically significant. The KODAK DirectView CR 800 and KODAK DirectView CR 900 with grid suppression are substantially equivalent to the previously cleared device [K923544]. KODAK DirectView CR 800 and CR 900 Systems 67 510(k) Submission ’ aviCe, o EVICEy > G, ntALTy o 44, %, "'fié… | 1992 |
What descends from it? (88)
See all 882 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 30, 2014 | Class II | Z-0820-2015 | Software design | Reduced mammographic image quality when attempting to print true size multi-format images |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090318 (Carestream Health, Inc., 2009) has gone furthest, with 79 descendants of its own.
How does its category compare?
All MQB devicesMQB 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
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
The KODAK DirectView CR 800 System and the KODAK Direct View CR 900 System are compact laser scanners capable of reading the latent image formed on a storage phosphor imaging plate and producing a digital image for projection radiography applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020635 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020635: Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview CR 900 System, Catalog# 1170976.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020635
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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