510(k) · Cleared

Cleared

Mammography Pro, Model 13017, Diagnostic Pro W/ Mammography Option, Model 13205

K993598510(k) TraditionalCleared Jan 20, 200087-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 Jan 20, 2000 as substantially equivalent to K933632 (Vidar Systems Corp., 1993) after an 87-day review. Its family tree reaches back 1 generation to 1993. 1 later device descends from it.

Decided: Jan 20, 2000
Review: 87 days
Class: Class II
Product code: LMA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K933632 (1993). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK933632 Medscan 12Vidar Systems Corp. · 1993
This deviceK993598 Mammography Pro, Model 13017, Diagnostic Pro W/ Mammography Option…Vidar Systems Corp. · 2000
Descendant · cites it directly · 0 of its ownK130406 Diagnosticpro EdgeVidar Systems Corp. · 2013

Most influential descendants

Showing 1 of 1 · See all

K130406Diagnosticpro EdgeVidar Systems Corp. · 2013 · 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)	K993598	Mammography Pro, Model 13017, Diagnostic Pro W/ Mammography Option, Model 13205	Vidar Systems Corp.	2000	—
+1	K130406	Diagnosticpro Edge	Vidar Systems Corp.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0

FIG. 1 — Lineage of K993598, 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
*	K933632	Medscan 12 Summary 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, an electronic device used to conv…	Vidar Systems Corp.	1993	—

Also cleared against K933632: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K130406	Diagnosticpro Edge	Vidar Systems Corp.	2013	0

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.
Of its descendants, K130406 (Vidar Systems Corp., 2013) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K933632.

How does its category compare?

All LMA devices

LMA Digitizer, Image, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 MAMMOGRAPHY PRO and Diagnostic PRO-M film digitizers are intended for converting analog Medical x-ray films to digital images.

The devices are indicated for the digitization of mammography images for review and analysis, but not as the sole basis for screening or diagnosis.

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/K993598 · printed Nov 5, 2026

Cite this page

510(k) Report. “K993598: Mammography Pro, Model 13017, Diagnostic Pro W/ Mammography Option, Model 13205.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993598

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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