PMA · Approved
Recalled · Class II · 2014Kodak Directview Computed Radiography (CR) Mammography
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Health, Inc. · MUE Full Field Digital, System, X-Ray, Mammographic
Approved on Nov 3, 2010 through premarket approval, which rests on the device’s own clinical evidence after an 828-day review. 2 later devices descend from it. It has been recalled once.
- Decided
- Nov 3, 2010
- Review
- 828 days
- Class
- Class II
- Product code
- MUE
- Recalls
- 1
2 later devices descend from it, 2 citing it directly.
- This deviceP080018 Kodak Directview Computed Radiography (CR) MammographyCarestream Health, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK120246 Kodak Directview CR Mammography System (Using Carestream CR…Carestream Health, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK111646 Aspire CR for Mammography System (CRM); FCR Aspire CRN (Reader).…Fujifilm Medical System U.S.A., Inc. · 2011
Most influential descendants
Showing 2 of 2 · See all- K120246Kodak Directview CR Mammography System (Using Carestream CR Mammography Cassette with…Carestream Health, Inc. · 2012 · cites it directly0descendants
- K111646Aspire CR for Mammography System (CRM); FCR Aspire CRN (Reader). Note for General…Fujifilm Medical System U.S.A., Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P080018 | Kodak Directview Computed Radiography (CR) Mammography | Carestream Health, Inc. | 2010 | — |
| +1 | K120246 | Kodak Directview CR Mammography System (Using Carestream CR Mammography… | Carestream Health, Inc. | 2012 | — |
| +1 | K111646 | Aspire CR for Mammography System (CRM); FCR Aspire CRN (Reader). Note for… | Fujifilm Medical System U.S.A., Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUE? 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 MUE device
- #1 K253678 MAMMOMAT B.brilliant (11372950)score 13.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (2)
2 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, K120246 (Carestream Health, Inc., 2012) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MUE devicesMUE Full Field Digital, System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MUE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUE
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUE
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUE
40in 2025
MAUDE reports naming product code MUE, 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 | 6 | — | 0 | 0 |
| 2008 | 5 | — | 1 | 4 |
| 2009 | 8 | — | 1 | 3 |
| 2010 | 10 | — | 2 | 2 |
| 2011 | 10 | 192 | 5 | 10 |
| 2012 | 4 | 123 | 0 | 6 |
| 2013 | 7 | 207 | 0 | 11 |
| 2014 | 1 | — | 2 | 7 |
| 2015 | 1 | — | 0 | 6 |
| 2016 | 1 | — | 0 | 19 |
| 2017 | 8 | 95 | 6 | 115 |
| 2018 | 2 | — | 1 | 145 |
| 2019 | 2 | — | 1 | 80 |
| 2020 | 4 | 188 | 0 | 49 |
| 2021 | 4 | 164 | 0 | 25 |
| 2022 | 3 | 404 | 0 | 36 |
| 2023 | 1 | — | 1 | 29 |
| 2024 | 1 | — | 0 | 33 |
| 2025 | 3 | 255 | 4 | 40 |
| 2026 | 4 | 185 | 1 | — |
https://510kreport.com/device/P080018 · printed Nov 6, 2026
Cite this page
510(k) Report. “P080018: Kodak Directview Computed Radiography (CR) Mammography.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P080018
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026