510(k) · Cleared
ClearedMedscan 12
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 13, 1993 after a 139-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Dec 13, 1993
- Review
- 139 days
- Class
- Class II
- Product code
- LMA
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK933632 Medscan 12Vidar Systems Corp. · 1993
- Descendant · cites it directly · 4 of its ownK993597 PLLL, Teleradpro, Model 12714/12715, VXR-12 Plus, Model 8619/9617Vidar Systems Corp. · 1999
- Descendant · 2 generations on · 1 of its ownK102476 TeleradproVidar Systems Corp. · 2010
- Descendant · cites it directly · 1 of its ownK993598 Mammography Pro, Model 13017, Diagnostic Pro W/ Mammography Option…Vidar Systems Corp. · 2000
- Descendant · 3 generations on · 0 of its ownK130636 Teleradpro Edge; Teleradpro Edge HD-CCDVidar Systems Corp. · 2013
- Descendant · 2 generations on · 0 of its ownK130406 Diagnosticpro EdgeVidar Systems Corp. · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K993597PLLL, Teleradpro, Model 12714/12715, VXR-12 Plus, Model 8619/9617Vidar Systems Corp. · 1999 · cites it directly4descendants
- K102476TeleradproVidar Systems Corp. · 2010 · 2 generations on1descendant
- K993598Mammography Pro, Model 13017, Diagnostic Pro W/ Mammography Option, Model 13205Vidar Systems Corp. · 2000 · cites it directly1descendant
- K130636Teleradpro Edge; Teleradpro Edge HD-CCDVidar Systems Corp. · 2013 · 3 generations on0descendants
- K130406Diagnosticpro EdgeVidar Systems Corp. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933632 | Medscan 12 | Vidar Systems Corp. | 1993 | — |
| +1 | K993597 | PLLL, Teleradpro, Model 12714/12715, VXR-12 Plus, Model 8619/9617 | Vidar Systems Corp. | 1999 | — |
| +2 | K102476 | Teleradpro | Vidar Systems Corp. | 2010 | — |
| +1 | K993598 | Mammography Pro, Model 13017, Diagnostic Pro W/ Mammography Option, Model 13205 | Vidar Systems Corp. | 2000 | — |
| +3 | K130636 | Teleradpro Edge; Teleradpro Edge HD-CCD | Vidar Systems Corp. | 2013 | — |
| +2 | K130406 | Diagnosticpro Edge | Vidar Systems Corp. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
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?
- Of its descendants, K993597 (Vidar Systems Corp., 1999) has gone furthest, with 4 descendants of its own.
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 | — |
https://510kreport.com/device/K933632 · printed Nov 5, 2026
Cite this page
510(k) Report. “K933632: Medscan 12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K933632
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026