510(k) · Cleared

Cleared

LR Dicom Controller

K022658510(k) SpecialCleared Sep 6, 200228-day reviewClass II21 CFR 892.2040

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

Agfa Corp. · LMC Camera, Multi Format, Radiological

Cleared on Sep 6, 2002 as substantially equivalent to K964414 (Bayer Corp., Agfa Div., 1997) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 1997.

Decided: Sep 6, 2002
Review: 28 days
Class: Class II
Product code: LMC
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K964414 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK964414 LR 5200 Laser Film RecorderBayer Corp., Agfa Div. · 1997 · Recalled
1 generation backK012010 Modification to LR 5200 Film RecorderAgfa Corp. · 2001
This deviceK022658 LR Dicom ControllerAgfa Corp. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K964414	LR 5200 Laser Film Recorder	Bayer Corp., Agfa Div.	1997	1
−1	K012010	Modification to LR 5200 Film Recorder	Agfa Corp.	2001	—
0 (this device)	K022658	LR Dicom Controller	Agfa Corp.	2002	—

FIG. 1 — Lineage of K022658, 1997–2002Source: 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 LMC? 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? (2)

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
*	K964414	LR 5200 Laser Film Recorder Summary page 1 …A. LEGALLY MARKETED PREDICATE DEVICES The predicate device is the LR 5200 Printer and Controller, which was cleared originally by FDA on 5 November 1996 as K964414 and also w i t h clarified indications on 27 June 2001 as KO1 201 0. B. DEVICE DESCRIPTION The modification involve…	Bayer Corp., Agfa Div.	1997	1
*	K012010	Modification to LR 5200 Film Recorder	Agfa Corp.	2001	—

Also cleared against K964414: 2 other devices →

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 5 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
1 of the 2 ancestors has a recall of any class.
2 other devices also cite its predicate K964414.

How does its category compare?

All LMC devices

LMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LMC

2in 2014

2007high 3 (2009) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LMC

80in 2009

2007high 80 (2009)2026

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

Recalls per year · LMC

1in 2008

2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · LMC

2in 2018

2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code LMC, 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	1	—	0	0
2008	1	—	1	0
2009	3	80	0	0
2010	0	—	0	0
2011	1	—	0	0
2012	0	—	0	0
2013	0	—	0	1
2014	2	—	0	1
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	2
2019	0	—	0	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 LR 5200 Laser Film Recorder is indicated for use in providing diagnostic quality medical images on film for aid in physician diagnosis, including the printing of images from various digital imaging source modalities, including, but not limited to, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound, Computed Radiography, Digital Mammography, and Nuclear Medicine.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022658 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022658: LR Dicom Controller.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022658

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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