510(k) · Cleared
Recalled · 2003LR 5200 Laser Film Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp., Agfa Div. · LMC Camera, Multi Format, Radiological
Cleared on Jan 27, 1997 after an 83-day review. The FDA summary names its predicate without a number. 5 later devices descend from it. It has been recalled once.
- Decided
- Jan 27, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- LMC
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK964414 LR 5200 Laser Film RecorderBayer Corp., Agfa Div. · 1997
- Descendant · cites it directly · 3 of its ownK012010 Modification to LR 5200 Film RecorderAgfa Corp. · 2001
- Descendant · 2 generations on · 1 of its ownK033377 Fuji Medical Dry Laser Imagers, Models Drypix 7000, Drypix 5000 and…Fujifilm Medical System U.S.A., Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK083522 Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK022658 LR Dicom ControllerAgfa Corp. · 2002
- Descendant · cites it directly · 0 of its ownK972822 Imation SE-204 Laser ImagerImation Enterprises Corp. · 1997
Most influential descendants
Showing 5 of 5 · See all- K012010Modification to LR 5200 Film RecorderAgfa Corp. · 2001 · cites it directly3descendants
- K033377Fuji Medical Dry Laser Imagers, Models Drypix 7000, Drypix 5000 and FM-DP LFujifilm Medical System U.S.A., Inc. · 2004 · 2 generations on1descendant
- K083522Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009 · 3 generations on0descendants
- K022658LR Dicom ControllerAgfa Corp. · 2002 · cites it directly0descendants
- K972822Imation SE-204 Laser ImagerImation Enterprises Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964414 | LR 5200 Laser Film Recorder | Bayer Corp., Agfa Div. | 1997 | — |
| +1 | K012010 | Modification to LR 5200 Film Recorder | Agfa Corp. | 2001 | — |
| +2 | K033377 | Fuji Medical Dry Laser Imagers, Models Drypix 7000, Drypix 5000 and FM-DP L | Fujifilm Medical System U.S.A., Inc. | 2004 | — |
| +3 | K083522 | Sony UP-DF750 Digital Film Imager | Sony Electronics, Inc. | 2009 | — |
| +1 | K022658 | LR Dicom Controller | Agfa Corp. | 2002 | — |
| +1 | K972822 | Imation SE-204 Laser Imager | Imation Enterprises Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 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 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
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | — | Agfa LR 3300 Named without a submission number | |
| * | — | Agfa Compact L Named without a submission number | |
| * | — | DuPont LP 400 Named without a submission number | |
| * | — | Fuji FL-IMD Named without a submission number | |
| * | — | Polaroid Helios 1417 Named without a submission number |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2003 | Not classified | Z-0207-04 | Other | The GS1 circuit board may fail resulting in smoke or fire. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012010 (Agfa Corp., 2001) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LMC devicesLMC Camera, Multi Format, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMC
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · LMC
80in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LMC
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMC
2in 2018
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 is a laser based (Helium-neon) film recorder, designed for producing high quality gray scale diagnostic medical images, when interfaced to a host imaging device. Typical host imaging devices would include those of Magnetic Resonance, Computed Tomography, Ultrasound, Mammography, Digital Radiography, and Nuclear Medicine imaging modalities. The diseases and conditions that the device will aid in the diagnosis of, are those that are typical to radiological types of examinations.
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/K964414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964414: LR 5200 Laser Film Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964414
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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