510(k) · Cleared
ClearedFuji Medical Dry Laser Imagers, Models Drypix 7000, Drypix 5000 and FM-DP L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical System U.S.A., Inc. · LMC Camera, Multi Format, Radiological
Cleared on Jan 9, 2004 as substantially equivalent to K012010 (Agfa Corp., 2001) and 1 other predicate after a 79-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Jan 9, 2004
- Review
- 79 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K964414 (1997). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK033377 Fuji Medical Dry Laser Imagers, Models Drypix 7000, Drypix 5000 and…Fujifilm Medical System U.S.A., Inc. · 2004
- Descendant · cites it directly · 0 of its ownK083522 Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K083522Sony UP-DF750 Digital Film ImagerSony Electronics, Inc. · 2009 · cites it directly0descendants
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) | K033377 | Fuji Medical Dry Laser Imagers, Models Drypix 7000, Drypix 5000 and FM-DP L | Fujifilm Medical System U.S.A., Inc. | 2004 | — |
| +1 | K083522 | Sony UP-DF750 Digital Film Imager | Sony Electronics, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 | Decided |
|---|---|---|---|
| * | K012010 | Modification to LR 5200 Film RecorderSummary page 2…dical Dry Laser Imagers models DRYPIX 7000, DRYPIX 5000 and FM-DP L are considered comparable and substantially equivalent to the Agfa LR 5200 Laser Film Recorder (K012010) manufactured by Agfa Corporation and the Kodak DRYVIEW 8610 Laser Imager (K002146) manufactured by the Eastman Kodak… | 2001 |
| * | K002146 | Kodak Dryview 8610 Laser Imager / for MammographySummary page 2…comparable and substantially equivalent to the Agfa LR 5200 Laser Film Recorder (K012010) manufactured by Agfa Corporation and the Kodak DRYVIEW 8610 Laser Imager (K002146) manufactured by the Eastman Kodak Company. SAFETY INFORMATION: Fuji Medical Dry Laser Imagers, models DRYPIX 70… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083522 | Sony UP-DF750 Digital Film Imager | 2009 | 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K083522 (Sony Electronics, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K012010.
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?
Fuji Medical Dry Laser Imagers, models DRYPIX 7000, DRYPIX 5000 and FM-DP L are indicated for use in providing diagnostic quality medical images on film for aid in physician diagnosis, including the printing of images and associated identification information from various digital imaging source modalities, including but not limited to, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Ultrasound, Computed Radiography, Digital Radiography, Digital Mammography and Nuclear Medicine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033377 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033377: Fuji Medical Dry Laser Imagers, Models Drypix 7000, Drypix 5000 and FM-DP L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033377
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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