510(k) · Cleared
ClearedMitra Imaging, Inc. Film Express Scanning Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitra Imaging, Inc. · LMD System, Digital Image Communications, Radiological
Cleared on May 2, 1997 after a 70-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- May 2, 1997
- Review
- 70 days
- Class
- Class I
- Product code
- LMD
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK970652 Mitra Imaging, Inc. Film Express Scanning SoftwareMitra Imaging, Inc. · 1997
- Descendant · cites it directly · 5 of its ownK980213 DI-2000Lumisys, Inc. · 1998
- Descendant · 2 generations on · 3 of its ownK020243 Laserpro 16Eradlink, Inc. · 2002
- Descendant · 3 generations on · 2 of its ownK052938 CR-PROEradlink, Inc. · 2005
- Descendant · 3 generations on · 1 of its ownK142718 Radlink GPSRadlink, Inc. · 2014
- Descendant · 4 generations on · 0 of its ownK242161 Radlink GPS Pro ImagingRadlink, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K980213DI-2000Lumisys, Inc. · 1998 · cites it directly5descendants
- K020243Laserpro 16Eradlink, Inc. · 2002 · 2 generations on3descendants
- K052938CR-PROEradlink, Inc. · 2005 · 3 generations on2descendants
- K142718Radlink GPSRadlink, Inc. · 2014 · 3 generations on1descendant
- K242161Radlink GPS Pro ImagingRadlink, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970652 | Mitra Imaging, Inc. Film Express Scanning Software | Mitra Imaging, Inc. | 1997 | — |
| +1 | K980213 | DI-2000 | Lumisys, Inc. | 1998 | — |
| +2 | K020243 | Laserpro 16 | Eradlink, Inc. | 2002 | — |
| +3 | K052938 | CR-PRO | Eradlink, Inc. | 2005 | — |
| +3 | K142718 | Radlink GPS | Radlink, Inc. | 2014 | — |
| +4 | K242161 | Radlink GPS Pro Imaging | Radlink, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2025 | 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 LMD? 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? (3)
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 |
|---|---|---|---|
| * | — | Lumisys DICOM TOOLKIT Named without a submission number | |
| * | — | Imageshare 910 Named without a submission number | |
| * | — | Statview Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980213 | DI-2000 | 1998 | 5 |
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?
- Of its descendants, K980213 (Lumisys, Inc., 1998) has gone furthest, with 5 descendants of its own.
How does its category compare?
All LMD devicesLMD System, Digital Image Communications, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMD
FDA has decided no LMD device since 2007.
Median 510(k) review, days · LMD
Too few LMD 510(k)s in any year since 2007 to give a median.
Recalls per year · LMD
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMD
16in 2025
MAUDE reports naming product code LMD, 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 | — | 2 | 1 |
| 2008 | 0 | — | 1 | 2 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 1 | 9 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 2 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K970652 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970652: Mitra Imaging, Inc. Film Express Scanning Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970652
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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