510(k) · Cleared
ClearedDrystar, Model 4500M
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 Nov 29, 2001 as substantially equivalent to K010275 (Agfa Medical Imaging, 2001) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 2000. 8 later devices descend from it.
- Decided
- Nov 29, 2001
- Review
- 90 days
- Class
- Class II
- Product code
- LMC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002146 (2000). 2 ancestors in all. 8 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK002146 Kodak Dryview 8610 Laser Imager / for MammographyEastman Kodak Company · 2000
- This deviceK012941 Drystar, Model 4500MAgfa Corp. · 2001
- Descendant · cites it directly · 6 of its ownK021054 Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon…Codonics, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK060440 Codonics Horizon XL Digital Direct Long Film Imager; Codonics…Codonics, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK042232 NP-2600 Series Hardcopy PrintersCodonics, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK024188 UP-DF500 Filmstation Digital Film ImagerSony Medical Systems · 2003
- Descendant · 2 generations on · 0 of its ownK111566 Dryview Chroma Imaging SystemCarestream Health, Inc. · 2011
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K021054Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical…Codonics, Inc. · 2002 · cites it directly6descendants
- K060440Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X Long Film…Codonics, Inc. · 2006 · 2 generations on1descendant
- K042232NP-2600 Series Hardcopy PrintersCodonics, Inc. · 2004 · 2 generations on1descendant
- K024188UP-DF500 Filmstation Digital Film ImagerSony Medical Systems · 2003 · 2 generations on1descendant
- K111566Dryview Chroma Imaging SystemCarestream Health, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002146 | Kodak Dryview 8610 Laser Imager / for Mammography | Eastman Kodak Company | 2000 | — |
| 0 (this device) | K012941 | Drystar, Model 4500M | Agfa Corp. | 2001 | — |
| +1 | K021054 | Codonics Horizon CI Medical Multimedia Dry Imager; Codonics Horizon GS Medical… | Codonics, Inc. | 2002 | — |
| +2 | K060440 | Codonics Horizon XL Digital Direct Long Film Imager; Codonics Horizon XL-X… | Codonics, Inc. | 2006 | — |
| +2 | K042232 | NP-2600 Series Hardcopy Printers | Codonics, Inc. | 2004 | — |
| +2 | K024188 | UP-DF500 Filmstation Digital Film Imager | Sony Medical Systems | 2003 | — |
| +2 | K111566 | Dryview Chroma Imaging System | Carestream Health, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K010275 | Drystar 4500 Printer, Model 4500 | 2001 |
| * | K002146 | Kodak Dryview 8610 Laser Imager / for MammographySummary page 1…ng of mammography images, the device is substantially equivalent to the Kodak Dryview 8610 Laser Imager for Mammography, which was cleared by FDA on 27 September 2000 as K002146. The Dryview 8610 also has a similar dry process thermal imaging technology to that of the Drystar 4500M. B. DEVICE DESCRIPTION… | 2000 |
What descends from it? (8)
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)
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 Drystar 4500M is a free-standing printer used to print diagnostic images on transparent film for viewing on a standard view box. It may be used in any situation in which a hard copy of an image generated by a medical imaging device is required or desirable, including digital mammography.
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/K012941 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012941: Drystar, Model 4500M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012941
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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