510(k) · Cleared
ClearedKodak Digital Science Film Digitizer L7501/L7506 (with Film Autofeeder)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kodak Health Imaging Systems, Inc. · LMA Digitizer, Image, Radiological
Cleared on Aug 22, 1996 as substantially equivalent to K915362 (Vortech Data, Inc., 1992) after a 106-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Aug 22, 1996
- Review
- 106 days
- Class
- Class II
- Product code
- LMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915362 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK915362 Vortech's Film Digitizer, FD-1Vortech Data, Inc. · 1992
- This deviceK961768 Kodak Digital Science Film Digitizer L7501/L7506 (with Film…Kodak Health Imaging Systems, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK971894 Kodak Digital Science - Dental Scanning SystemEastman Kodak Company · 1997
Most influential descendants
Showing 1 of 1 · See all- K971894Kodak Digital Science - Dental Scanning SystemEastman Kodak Company · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915362 | Vortech's Film Digitizer, FD-1 | Vortech Data, Inc. | 1992 | — |
| 0 (this device) | K961768 | Kodak Digital Science Film Digitizer L7501/L7506 (with Film Autofeeder) | Kodak Health Imaging Systems, Inc. | 1996 | — |
| +1 | K971894 | Kodak Digital Science - Dental Scanning System | Eastman Kodak Company | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K915362 | Vortech's Film Digitizer, FD-1Summary page 2…ing and Communication System (PACS). IX. Substantial Equivalence The purpose and functionality of the KDS FD is substantially similar to the Vortech (Kodak) FD system (K915362, November 27, 1991), as well as numerous other x-ray digitizers currently on the market. The basis for the equivalence is that bo… | 1992 |
| * | — | KODAK Film Digitizer (“FD”) Named without a submission number |
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 |
|---|---|---|---|
| K971894 | Kodak Digital Science - Dental Scanning System | 1997 | 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?
- Its one ancestor has no recall.
- Of its descendants, K971894 (Eastman Kodak Company, 1997) has gone furthest, with 0 descendants 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 KDS FD is designed to allow operators and physicians greater access to images by transmitting them electronically over networks instead of physically sending films. The system allows for much quicker consultations with experts in distant facilities. Also, archiving electronically for faster image recall and assembly of historical studies can be accomplished with ease. The KDS FD is a DICOM conformant digitization product designed for use within a Picture Archiving and Communication System (PACS).
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/K961768 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961768: Kodak Digital Science Film Digitizer L7501/L7506 (with Film Autofeeder).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961768
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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