510(k) · Cleared
ClearedFCR DMS Optical Disk Image Filing Unit OD-F614, ODF614L & Multimodality System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical System U.S.A., Inc. · LMB Device, Digital Image Storage, Radiological
Cleared on Mar 7, 1996 as substantially equivalent to K921112 (Fujifilm Medical System U.S.A., Inc., 1993) after a 43-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.
- Decided
- Mar 7, 1996
- Review
- 43 days
- Class
- Class I
- Product code
- LMB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921112 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK921112 Fuji Computed Radiography OD-F623 Optical-DiskFujifilm Medical System U.S.A., Inc. · 1993
- This deviceK960326 FCR DMS Optical Disk Image Filing Unit OD-F614, ODF614L &…Fujifilm Medical System U.S.A., Inc. · 1996
- Descendant · cites it directly · 0 of its ownK980243 Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet…Parameter Developments, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK970293 Fuji Computed Radiography FCR/Dicom Gateway Unit CR-DM666Fujifilm Medical System U.S.A., Inc. · 1997
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 | K921112 | Fuji Computed Radiography OD-F623 Optical-Disk | Fujifilm Medical System U.S.A., Inc. | 1993 | — |
| 0 (this device) | K960326 | FCR DMS Optical Disk Image Filing Unit OD-F614, ODF614L & Multimodality System | Fujifilm Medical System U.S.A., Inc. | 1996 | — |
| +1 | K980243 | Parameter Developments Dicom Archival Server, (Das)/Dicom Intranet Service (Dis) | Parameter Developments, Inc. | 1998 | — |
| +1 | K970293 | Fuji Computed Radiography FCR/Dicom Gateway Unit CR-DM666 | Fujifilm Medical System U.S.A., Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 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 LMB? 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? (1)
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 |
|---|---|---|---|
| * | K921112 | Fuji Computed Radiography OD-F623 Optical-DiskSummary page 1…D-F623 to regulatory class II, with FDA product code RA 90 KPR (system, X-ray, stationary) citing 21 CFR § 892.1680. FDA'’s accession number for the predicate device is K921112/B. FDA cleared the marketing of the predicate device in a letter dated April 27, 1993. Description of the Device [21 CFR 807.92(… | 1993 |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K980243 (Parameter Developments, Inc., 1998) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LMB devicesLMB Device, Digital Image Storage, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMB
FDA has decided no LMB device since 2007.
Median 510(k) review, days · LMB
Too few LMB 510(k)s in any year since 2007 to give a median.
Recalls per year · LMB
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMB
7in 2025
MAUDE reports naming product code LMB, 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 | 1 |
| 2008 | 0 | — | 1 | 3 |
| 2009 | 0 | — | 5 | 3 |
| 2010 | 0 | — | 0 | 16 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 1 | 7 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 21 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The subject devices share the intended use of the predicate OD-F623: the storage of FCR image with patient identification data. The subject devices add the additional capability to store image and patient identification data from sources other than computed radiography image readers.
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/K960326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960326: FCR DMS Optical Disk Image Filing Unit OD-F614, ODF614L & Multimodality System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960326
Report an extraction error
Are you the manufacturer?
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