510(k) · Cleared
ClearedKodak Directview CR Cassette/GP/15 X 30 CM, Catalog# 8418253
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eastman Kodak Company · IXA Cassette, Radiographic Film
Cleared on May 24, 2004 as substantially equivalent to K925997 (Eastman Kodak Company, 1992) after a 97-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- May 24, 2004
- Review
- 97 days
- Class
- Class II
- Product code
- IXA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925997 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK925997 Kodak Ektascan SP CassetteEastman Kodak Company · 1992 · Recalled
- This deviceK040378 Kodak Directview CR Cassette/GP/15 X 30 CM, Catalog# 8418253Eastman Kodak Company · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925997 | Kodak Ektascan SP Cassette | Eastman Kodak Company | 1992 | 1 |
| 0 (this device) | K040378 | Kodak Directview CR Cassette/GP/15 X 30 CM, Catalog# 8418253 | Eastman Kodak Company | 2004 | — |
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 IXA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K925997 | Kodak Ektascan SP CassetteSummary page 2…, 2002). 8. Substantial Equivalence The KODAK DirectView CR 15 x 30 cm cassette is substantially equivalent to the Kodak Ektascan SP Cassette (K925997), previously cleared on December 17, 1992. The Kodak Ektascan SP Cassette is currently marketed as the Kodak Direc… | 1992 |
| † | K020635 | Kodak Directview CR 800 System, Catalog# 1268622; Kodak Directview CR 900 System… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
How does its category compare?
All IXA devicesIXA Cassette, Radiographic Film: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXA
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · IXA
Too few IXA 510(k)s in any year since 2007 to give a median.
Recalls per year · IXA
No recall names IXA since 2007.
Adverse event reports per year · IXA
1in 2014
MAUDE reports naming product code IXA, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The KODAK DirectView CR cassette holds a storage phosphor screen which is exposed by radiographic equipment for the recording of a patient radiation pattern. The cassette is loaded into a compact laser scanner capable of reading the latent image. The Kodak DirectView CR 15 x 30 cm cassette and storage phosphor screen can be used for general radiology and dental panoramic radiography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040378: Kodak Directview CR Cassette/GP/15 X 30 CM, Catalog# 8418253.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040378
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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