510(k) · Cleared
ClearedVidar VXR LS Laser Film Digitizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vidar Systems Corp. · LMA Digitizer, Image, Radiological
Cleared on Apr 17, 1998 as substantially equivalent to K934496 (Camtronics, Ltd., 1993) after a 151-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Apr 17, 1998
- Review
- 151 days
- Class
- Class II
- Product code
- LMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934496 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK934496 X-Ray Angiographic SystemCamtronics, Ltd. · 1993
- This deviceK974315 Vidar VXR LS Laser Film DigitizerVidar Systems Corp. · 1998
- Descendant · cites it directly · 0 of its ownK992112 Samsung Raypax Film DigitizerSamsung Sds Co., Ltd. · 1999
- Descendant · cites it directly · 0 of its ownK984409 Elk Laser Film DigitizerNishimoto Sangyo Co., Ltd. · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934496 | X-Ray Angiographic System | Camtronics, Ltd. | 1993 | — |
| 0 (this device) | K974315 | Vidar VXR LS Laser Film Digitizer | Vidar Systems Corp. | 1998 | — |
| +1 | K992112 | Samsung Raypax Film Digitizer | Samsung Sds Co., Ltd. | 1999 | — |
| +1 | K984409 | Elk Laser Film Digitizer | Nishimoto Sangyo Co., Ltd. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 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 LMA? 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 |
|---|---|---|---|
| * | K934496 | X-Ray Angiographic SystemSummary page 1…assification: Medical image digitizers were reviewed by the Radiology Panel and are classified in Class Il per 21CFR 892.2040 (proposed). Predicate Device: Lumiscan 75 (K934496). Manufactured by: Lumisys. Inc., 225 Humboldt Court, Sunnyvale, California 94089, Description of Device: The Vidar VXR-LS is… | 1993 |
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All LMA devicesLMA Digitizer, Image, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMA
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · LMA
80in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LMA
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMA
1in 2013
MAUDE reports naming product code LMA, 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 | 0 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 3 | 80 | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 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 Vidar VXR-LS Film Digitizer is intended for producing digital copies of medical x-ray films.
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/K974315 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974315: Vidar VXR LS Laser Film Digitizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974315
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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