510(k) · Cleared
ClearedFuji Computed Radiograp HI-C654 DMS CRT Image Cons
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical System U.S.A., Inc. · IXK System, Imaging, X-Ray, Electrostatic
Cleared on Jun 8, 1993 after a 102-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jun 8, 1993
- Review
- 102 days
- Class
- Class II
- Product code
- IXK
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK931002 Fuji Computed Radiograp HI-C654 DMS CRT Image ConsFujifilm Medical System U.S.A., Inc. · 1993
- Descendant · cites it directly · 3 of its ownK972256 FCR Fuji Computed Radiography DMS CRT Image Console HI-C654 (for…Fujifilm Medical System U.S.A., Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK013218 Fuji Speed Suite, Fuji Speed Sute Phase IIFujifilm Medical System U.S.A., Inc. · 2001 · Recalled
- Descendant · 3 generations on · 0 of its ownK091631 Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK991257 Fuji Wavelet Compression or Ffcomp Irreversible CompressionFujifilm Medical System U.S.A., Inc. · 1999 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K972256FCR Fuji Computed Radiography DMS CRT Image Console HI-C654 (for Networks)Fujifilm Medical System U.S.A., Inc. · 1997 · cites it directly3descendants
- K013218Fuji Speed Suite, Fuji Speed Sute Phase IIFujifilm Medical System U.S.A., Inc. · 2001 · 2 generations on1descendant
- K091631Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc. · 2010 · 3 generations on0descendants
- K991257Fuji Wavelet Compression or Ffcomp Irreversible CompressionFujifilm Medical System U.S.A., Inc. · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931002 | Fuji Computed Radiograp HI-C654 DMS CRT Image Cons | Fujifilm Medical System U.S.A., Inc. | 1993 | — |
| +1 | K972256 | FCR Fuji Computed Radiography DMS CRT Image Console HI-C654 (for Networks) | Fujifilm Medical System U.S.A., Inc. | 1997 | — |
| +2 | K013218 | Fuji Speed Suite, Fuji Speed Sute Phase II | Fujifilm Medical System U.S.A., Inc. | 2001 | 1 |
| +3 | K091631 | Accessnet, Accessmed, Accessrad, Medview | Aspyra, Inc. | 2010 | — |
| +2 | K991257 | Fuji Wavelet Compression or Ffcomp Irreversible Compression | Fujifilm Medical System U.S.A., Inc. | 1999 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IXK? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972256 | FCR Fuji Computed Radiography DMS CRT Image Console HI-C654 (for Networks) | 1997 | 3 |
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, K972256 (Fujifilm Medical System U.S.A., Inc., 1997) has gone furthest, with 3 descendants of its own.
How does its category compare?
All IXK devicesIXK System, Imaging, X-Ray, Electrostatic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXK
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · IXK
Too few IXK 510(k)s in any year since 2007 to give a median.
Recalls per year · IXK
No recall names IXK since 2007.
Adverse event reports per year · IXK
No MAUDE report names IXK since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 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 | — |
https://510kreport.com/device/K931002 · printed Nov 6, 2026
Cite this page
510(k) Report. “K931002: Fuji Computed Radiograp HI-C654 DMS CRT Image Cons.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931002
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026