510(k) · Cleared
ClearedDiffuser Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focused Viewer, Inc. · IXC Illuminator, Radiographic-Film
Cleared on Mar 11, 1997 as substantially equivalent to K875233 (Diversified Diagnostic Products, Inc., 1988) after a 48-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Mar 11, 1997
- Review
- 48 days
- Class
- Class I
- Product code
- IXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K875233 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK875233 Variviewer (X-Ray Film Viewer)Diversified Diagnostic Products, Inc. · 1988
- This deviceK970240 Diffuser PanelFocused Viewer, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K875233 | Variviewer (X-Ray Film Viewer) | Diversified Diagnostic Products, Inc. | 1988 | — |
| 0 (this device) | K970240 | Diffuser Panel | Focused Viewer, Inc. | 1997 | — |
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 IXC? 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 |
|---|---|---|---|
| * | K875233 | Variviewer (X-Ray Film Viewer)Summary page 1…(21 CFR 892.1890) 3. Legally Marketed Equivalent Device Name We are claiming substantial equivalence to the panel marketed by Diversified Diagnostic Products. Refer to K875233. Original 510(K). January, 1997. 10 Focused Viewer, Inc. Radiographic Film Hiuminator 510(k) Notification 510(… | 1988 |
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 IXC devicesIXC Illuminator, Radiographic-Film: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXC
FDA has decided no IXC device since 2007.
Median 510(k) review, days · IXC
Too few IXC 510(k)s in any year since 2007 to give a median.
Recalls per year · IXC
No recall names IXC since 2007.
Adverse event reports per year · IXC
No MAUDE report names IXC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 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 Diffuser Panel is designed to diffuse the light from the light source in Radiographic Film Illuminators.
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/K970240 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970240: Diffuser Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970240
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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