510(k) · Cleared
ClearedImagclear Mammography Review System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dba Systems, Inc. · LMA Digitizer, Image, Radiological
Cleared on Feb 10, 2000 as substantially equivalent to K932760 (Dba Systems, Inc., 1994) and 1 other predicate after a 202-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Feb 10, 2000
- Review
- 202 days
- Class
- Class II
- Product code
- LMA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932760 (1994). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK932760 DFS-2100Dba Systems, Inc. · 1994
- This deviceK992467 Imagclear Mammography Review SystemDba Systems, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK031132 Consultiva Case Input Station, Model Cis-1Eastman Kodak Company · 2003
- Descendant · 2 generations on · 0 of its ownK061160 M-VU Cad StationVucomp, Inc. · 2006
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932760 | DFS-2100 | Dba Systems, Inc. | 1994 | — |
| 0 (this device) | K992467 | Imagclear Mammography Review System | Dba Systems, Inc. | 2000 | — |
| +1 | K031132 | Consultiva Case Input Station, Model Cis-1 | Eastman Kodak Company | 2003 | — |
| +2 | K061160 | M-VU Cad Station | Vucomp, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 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 LMA? 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 |
|---|---|---|---|
| * | K932760 | DFS-2100Summary page 1…n or Usual Name ImagClear® System Classification Name Picture Archiving and Communication System Predicate Devices DBA'’s previously cleared ImagClear® Film Digitizer (K932760) and MedImage, Inc.’s Galen™ Software (K946334) Intended Use The ImagClear® System is intended to digitize analog medical image… | 1994 |
| * | K946334 | GALENSummary page 1…n Name Picture Archiving and Communication System Predicate Devices DBA'’s previously cleared ImagClear® Film Digitizer (K932760) and MedImage, Inc.’s Galen™ Software (K946334) Intended Use The ImagClear® System is intended to digitize analog medical images, which will be viewed, archived, or electroni… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031132 | Consultiva Case Input Station, Model Cis-1 | 2003 | 1 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K031132 (Eastman Kodak Company, 2003) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LMA devicesLMA Digitizer, Image, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMA
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · LMA
80in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LMA
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMA
1in 2013
MAUDE reports naming product code LMA, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 3 | 80 | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 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 ImagClear® Mammography Review System is intended to digitize analog medical images, which will be viewed, archived, or electronically shared with other health care professionals. The ImagClear® System is specifically indicated for the digitization of mammographic images for review and analysis, but not as the sole basis for screening or diagnosis.
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/K992467 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992467: Imagclear Mammography Review System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992467
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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