510(k) · Cleared

Cleared

Teleradpro Edge; Teleradpro Edge HD-CCD

K130636510(k) TraditionalCleared Jun 7, 201388-day reviewClass II21 CFR 892.2030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vidar Systems Corp. · LMA Digitizer, Image, Radiological

Cleared on Jun 7, 2013 as substantially equivalent to K102476 (Vidar Systems Corp., 2010) after an 88-day review. Its family tree reaches back 3 generations to 1993.

Decided: Jun 7, 2013
Review: 88 days
Class: Class II
Product code: LMA
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K933632 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK933632 Medscan 12Vidar Systems Corp. · 1993
2 generations backK993597 PLLL, Teleradpro, Model 12714/12715, VXR-12 Plus, Model 8619/9617Vidar Systems Corp. · 1999
1 generation backK102476 TeleradproVidar Systems Corp. · 2010
This deviceK130636 Teleradpro Edge; Teleradpro Edge HD-CCDVidar Systems Corp. · 2013

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K933632	Medscan 12	Vidar Systems Corp.	1993	—
−2	K993597	PLLL, Teleradpro, Model 12714/12715, VXR-12 Plus, Model 8619/9617	Vidar Systems Corp.	1999	—
−1	K102476	Teleradpro	Vidar Systems Corp.	2010	—
0 (this device)	K130636	Teleradpro Edge; Teleradpro Edge HD-CCD	Vidar Systems Corp.	2013	—

FIG. 1 — Lineage of K130636, 1993–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K102476	Teleradpro Summary page 1 …D-CCD Common Name: X-Ray Film Digitizer Classification Name: Medical Image Digitizer (21CFR892.2030) Product Code: LMA Predicate Device: Trade Name: TeleradPRO 510(k): K102476 Manufacturer: VIDAR Systems Corporation Device Description: The device consists of a film digitizer with single-film or multi-f…	Vidar Systems Corp.	2010	—

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?

The line of descent spans 20 years and passes through 1 company; a new generation was cleared every 6.0 years on median.
None of the 3 ancestors has a recall.

How does its category compare?

All LMA devices

LMA Digitizer, Image, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · LMA

3in 2013

2007high 3 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LMA

80in 2013

2007high 80 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LMA

1in 2019

2007high 1 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LMA

1in 2013

2007high 3 (2008) · low 0 (2007)2025

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 TeleradPRO Edge and TeleradPRO Edge HD-CCD digitizers are used for making digital copies of medical x-ray film, including printed and radiographic film. The target users of these devices are medical professionals or trained staff for use as secondary capture images for consultation, review and final interpretation.

These devices are not intended to be used for primary diagnosis in mammography applications.

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/K130636 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130636: Teleradpro Edge; Teleradpro Edge HD-CCD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130636

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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