510(k) · Cleared
ClearedDS Cassette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Konica Minolta Medical & Graphic, Inc. · IXA Cassette, Radiographic Film
Cleared on Dec 15, 2005 as substantially equivalent to K963914 (Konica Medical Corp., 1997) after a 31-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Dec 15, 2005
- Review
- 31 days
- Class
- Class II
- Product code
- IXA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963914 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK963914 CM & CM DS-7Konica Medical Corp. · 1997
- This deviceK053173 DS CassetteKonica Minolta Medical & Graphic, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963914 | CM & CM DS-7 | Konica Medical Corp. | 1997 | — |
| 0 (this device) | K053173 | DS Cassette | Konica Minolta Medical & Graphic, Inc. | 2005 | — |
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 |
|---|---|---|---|
| * | K963914 | CM & CM DS-7Summary page 2…10. Substantial Equivalence to Predicate Device The DS Cassette is substantially equivalent to Konica Mammography Cassettes; Models CM and CM DS-7, 510(k) number: K963914. 11. Technological Characteristics The technological characteristics of the DS Cassette are the same as those of the p… | 1997 |
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 no 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 DS Cassette is intended for use during diagnostic x-ray procedures to hold a radiographic film in close contact with an x-ray intensifying screen and 'to provide a light-proof enclosure for direct exposure of radiographic film. It is not intended for mammography use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053173 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053173: DS Cassette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053173
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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