510(k) · Cleared
ClearedSmart Motorized Viewer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smartlight, Ltd. · IXC Illuminator, Radiographic-Film
Cleared on Dec 12, 1997 as substantially equivalent to K922079 (American Medical Sales, Inc., 1992) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Dec 12, 1997
- Review
- 56 days
- Class
- Class I
- Product code
- IXC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K922079 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK922079 Rotolux, Selectolux, ShuttervueAmerican Medical Sales, Inc. · 1992
- This deviceK973965 Smart Motorized ViewerSmartlight, Ltd. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922079 | Rotolux, Selectolux, Shuttervue | American Medical Sales, Inc. | 1992 | — |
| 0 (this device) | K973965 | Smart Motorized Viewer | Smartlight, Ltd. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 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 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? (3)
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 |
|---|---|---|---|
| * | K922079 | Rotolux, Selectolux, ShuttervueSummary page 1…ctro-optical shutter asembly, CCD based film detection assembly and PC-based control hardware and software. Predicate devices include AMS/Planilux Rotolux and Mammolux (K922079), S&S/RADX MV220/MV400 and SmartLight’s Digital Film Viewer SL4000”% (K952188). The indication for use of the predicate devices a… | 1992 |
| * | K952188 | Adviewer 2000Summary page 1…ontrol hardware and software. Predicate devices include AMS/Planilux Rotolux and Mammolux (K922079), S&S/RADX MV220/MV400 and SmartLight’s Digital Film Viewer SL4000”% (K952188). The indication for use of the predicate devices and the SL8000” X is radiographic film reading. The SL8000”“* restricts the ba… | 1995 |
| * | — | S&S/Radx MV220/MV400 Named without a submission number |
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?
- None of the 2 ancestors has a 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?
Radiographic Film Reading
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/K973965 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973965: Smart Motorized Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973965
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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