510(k) · Cleared
ClearedModification to LR 5200 Film Recorder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Corp. · LMC Camera, Multi Format, Radiological
Cleared on Sep 20, 2001 as substantially equivalent to K964414 (Bayer Corp., Agfa Div., 1997) after an 85-day review. Its family tree reaches back 1 generation to 1997. 3 later devices descend from it.
- Decided
- Sep 20, 2001
- Review
- 85 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964414 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK964414 LR 5200 Laser Film RecorderBayer Corp., Agfa Div. · 1997 · Recalled
- This deviceK012010 Modification to LR 5200 Film RecorderAgfa Corp. · 2001
- Descendant · cites it directly · 1 of its ownK033377 Fuji Medical Dry Laser Imagers, Models Drypix 7000, Drypix 5000 and…Fujifilm Medical System U.S.A., Inc. · 2004
- Descendant · 2 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
Most influential descendants
Showing 3 of 3 · See all- K033377Fuji Medical Dry Laser Imagers, Models Drypix 7000, Drypix 5000 and FM-DP LFujifilm Medical System U.S.A., Inc. · 2004 · cites it directly1descendant
- K083522Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009 · 2 generations on0descendants
- K022658LR Dicom ControllerAgfa Corp. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964414 | LR 5200 Laser Film Recorder | Bayer Corp., Agfa Div. | 1997 | 1 |
| 0 (this device) | K012010 | Modification to LR 5200 Film Recorder | Agfa Corp. | 2001 | — |
| +1 | K033377 | Fuji Medical Dry Laser Imagers, Models Drypix 7000, Drypix 5000 and FM-DP L | Fujifilm Medical System U.S.A., Inc. | 2004 | — |
| +2 | K083522 | Sony UP-DF750 Digital Film Imager | Sony Electronics, Inc. | 2009 | — |
| +1 | K022658 | LR Dicom Controller | Agfa Corp. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 | Decided |
|---|---|---|---|
| * | K964414 | LR 5200 Laser Film RecorderSummary page 1…C 29602-9048 Contact: Jeff Jedlicka, Prepared: June 20, 2001 LEGALLY MARKETED PREDICATE DEVICES The LR5200 was cleared for marketing through the premarket notification K964414 on January 27, 1997. The LR5200 with revised indications for use statement is substantially equivalent to the currently marketed… | 1997 |
What descends from it? (3)
2 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?
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 LR5200 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012010 · printed Nov 3, 2026
Cite this page
510(k) Report. “K012010: Modification to LR 5200 Film Recorder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K012010
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026