510(k) · Cleared
ClearedFCR Fuji Computed Radiography DMS CRT Image Console HI-C654 (for Networks)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical System U.S.A., Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 12, 1997 as substantially equivalent to K931002 (Fujifilm Medical System U.S.A., Inc., 1993) after an 88-day review. Its family tree reaches back 1 generation to 1993. 3 later devices descend from it.
- Decided
- Sep 12, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931002 (1993). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK931002 Fuji Computed Radiograp HI-C654 DMS CRT Image ConsFujifilm Medical System U.S.A., Inc. · 1993
- This deviceK972256 FCR Fuji Computed Radiography DMS CRT Image Console HI-C654 (for…Fujifilm Medical System U.S.A., Inc. · 1997
- Descendant · cites it directly · 1 of its ownK013218 Fuji Speed Suite, Fuji Speed Sute Phase IIFujifilm Medical System U.S.A., Inc. · 2001 · Recalled
- Descendant · 2 generations on · 0 of its ownK091631 Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK991257 Fuji Wavelet Compression or Ffcomp Irreversible CompressionFujifilm Medical System U.S.A., Inc. · 1999 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K013218Fuji Speed Suite, Fuji Speed Sute Phase IIFujifilm Medical System U.S.A., Inc. · 2001 · cites it directly1descendant
- K091631Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc. · 2010 · 2 generations on0descendants
- K991257Fuji Wavelet Compression or Ffcomp Irreversible CompressionFujifilm Medical System U.S.A., Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931002 | Fuji Computed Radiograp HI-C654 DMS CRT Image Cons | Fujifilm Medical System U.S.A., Inc. | 1993 | — |
| 0 (this device) | K972256 | FCR Fuji Computed Radiography DMS CRT Image Console HI-C654 (for Networks) | Fujifilm Medical System U.S.A., Inc. | 1997 | — |
| +1 | K013218 | Fuji Speed Suite, Fuji Speed Sute Phase II | Fujifilm Medical System U.S.A., Inc. | 2001 | 1 |
| +2 | K091631 | Accessnet, Accessmed, Accessrad, Medview | Aspyra, Inc. | 2010 | — |
| +1 | 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 |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2010 | 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 LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K931002 | Fuji Computed Radiograp HI-C654 DMS CRT Image ConsSummary page 1…ct code IXK as a regulatory class II medical device “System, Imaging, X-ray, Electro- static”, citing 21 CFR § 892.1630 “Electrostatic X-ray Imaging System” under 510(k) K931002. Under FDA’s proposed rules (61 FR 63774 of December 2, 1996) Fuji believes FDA would classify this device as Class I1, 21CFR 892… | 1993 |
What descends from it? (3)
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, K013218 (Fujifilm Medical System U.S.A., Inc., 2001) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The indication for use of the FCR® Fuji Computed Radiography DMS CRT Image Console HI-C654 Multimodality Display System for Networks is to receive, process, display, and transmit medical images.
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/K972256 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972256: FCR Fuji Computed Radiography DMS CRT Image Console HI-C654 (for Networks).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972256
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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