510(k) · Cleared
ClearedDiagnostic Pro, Model 12772, VXR-16, Model 13020, VXR-16 Dosimetry Pro, Model 13019
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 Jan 18, 2000 as substantially equivalent to K933632 (Vidar Systems Corp., 1993) after an 85-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jan 18, 2000
- Review
- 85 days
- Class
- Class II
- Product code
- LMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933632 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK933632 Medscan 12Vidar Systems Corp. · 1993
- This deviceK993599 Diagnostic Pro, Model 12772, VXR-16, Model 13020, VXR-16 Dosimetry…Vidar Systems Corp. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933632 | Medscan 12 | Vidar Systems Corp. | 1993 | — |
| 0 (this device) | K993599 | Diagnostic Pro, Model 12772, VXR-16, Model 13020, VXR-16 Dosimetry Pro, Model… | Vidar Systems Corp. | 2000 | — |
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 |
|---|---|---|---|
| * | K933632 | Medscan 12Summary page 1…digitizers. X-ray film digitizer Medical image digitizers were reviewed by the Radiology panel and are classified in Class 11 per CFR 892.2040 (proposed). MedScan 12 (K933632) VIDAR Systems Corporation, 460 Spring Park Place, Herndon, VA 20170 The x-ray film digitizer is an electronic device that conve… | 1993 |
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.
- 2 other devices also cite its predicate K933632.
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 Diagnostic PRO, VXR-16, and VXR-16 DOSIMETRYPRO film digitizers are intended for making 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/K993599 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993599: Diagnostic Pro, Model 12772, VXR-16, Model 13020, VXR-16 Dosimetry Pro, Model 13019.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993599
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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