510(k) · Cleared
ClearedPLLL, Teleradpro, Model 12714/12715, VXR-12 Plus, Model 8619/9617
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 Dec 15, 1999 as substantially equivalent to K933632 (Vidar Systems Corp., 1993) after a 51-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.
- Decided
- Dec 15, 1999
- Review
- 51 days
- Class
- Class II
- Product code
- LMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933632 (1993). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK933632 Medscan 12Vidar Systems Corp. · 1993
- This deviceK993597 PLLL, Teleradpro, Model 12714/12715, VXR-12 Plus, Model 8619/9617Vidar Systems Corp. · 1999
- Descendant · cites it directly · 1 of its ownK102476 TeleradproVidar Systems Corp. · 2010
- Descendant · 2 generations on · 0 of its ownK130636 Teleradpro Edge; Teleradpro Edge HD-CCDVidar Systems Corp. · 2013
- Descendant · cites it directly · 0 of its ownK093809 Vidar Dental Film DigitizerVidar Systems Corp. · 2010
- Descendant · cites it directly · 0 of its ownK091288 Medi-6000 Medical Image DigitizerMicrotek International, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K102476TeleradproVidar Systems Corp. · 2010 · cites it directly1descendant
- K130636Teleradpro Edge; Teleradpro Edge HD-CCDVidar Systems Corp. · 2013 · 2 generations on0descendants
- K093809Vidar Dental Film DigitizerVidar Systems Corp. · 2010 · cites it directly0descendants
- K091288Medi-6000 Medical Image DigitizerMicrotek International, Inc. · 2009 · cites it directly0descendants
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) | K993597 | PLLL, Teleradpro, Model 12714/12715, VXR-12 Plus, Model 8619/9617 | Vidar Systems Corp. | 1999 | — |
| +1 | K102476 | Teleradpro | Vidar Systems Corp. | 2010 | — |
| +2 | K130636 | Teleradpro Edge; Teleradpro Edge HD-CCD | Vidar Systems Corp. | 2013 | — |
| +1 | K093809 | Vidar Dental Film Digitizer | Vidar Systems Corp. | 2010 | — |
| +1 | K091288 | Medi-6000 Medical Image Digitizer | Microtek International, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 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 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 used to co… | 1993 |
What descends from it? (4)
3 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 P 111, TeleRADPRO, and VXR-12 plus 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/K993597 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993597: PLLL, Teleradpro, Model 12714/12715, VXR-12 Plus, Model 8619/9617.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993597
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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