510(k) · Cleared
Recalled · 2004Fuji Computed Radiography Dual Side Reading, Both Side Reading, FCR 5501D Dual Side Reader
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical System U.S.A., Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Feb 10, 2000 as substantially equivalent to K944046 (Fujifilm Medical System U.S.A., Inc., 1995) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1995. 82 later devices descend from it. It has been recalled once.
- Decided
- Feb 10, 2000
- Review
- 87 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K944046 (1995). 2 ancestors in all. 82 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK944046 Fuji Computed Radiography SystemsFujifilm Medical System U.S.A., Inc. · 1995 · Recalled
- This deviceK993861 Fuji Computed Radiography Dual Side Reading, Both Side Reading, FCR…Fujifilm Medical System U.S.A., Inc. · 2000
- Descendant · cites it directly · 78 of its ownK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- Descendant · 2 generations on · 34 of its ownK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- Descendant · 2 generations on · 30 of its ownK120020 Vivix-SVieworks Co., Ltd. · 2012
- Descendant · 3 generations on · 28 of its ownK122865 Vivix-S WirelessVieworks Co., Ltd. · 2013
- Descendant · 3 generations on · 25 of its ownK122736 DX-D Imaging PackageAgfa Healthcare N.V. · 2013
Showing 5 of 82 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 82 · See all- K024147Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003 · cites it directly78descendants
- K092669DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · 2 generations on34descendants
- K120020Vivix-SVieworks Co., Ltd. · 2012 · 2 generations on30descendants
- K122865Vivix-S WirelessVieworks Co., Ltd. · 2013 · 3 generations on28descendants
- K122736DX-D Imaging PackageAgfa Healthcare N.V. · 2013 · 3 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944046 | Fuji Computed Radiography Systems | Fujifilm Medical System U.S.A., Inc. | 1995 | 1 |
| 0 (this device) | K993861 | Fuji Computed Radiography Dual Side Reading, Both Side Reading, FCR 5501D Dual… | Fujifilm Medical System U.S.A., Inc. | 2000 | — |
| +1 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| +2 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| +2 | K120020 | Vivix-S | Vieworks Co., Ltd. | 2012 | — |
| +3 | K122865 | Vivix-S Wireless | Vieworks Co., Ltd. | 2013 | — |
| +3 | K122736 | DX-D Imaging Package | Agfa Healthcare N.V. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 6 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 9 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K944046 | Fuji Computed Radiography SystemsSummary page 1…de Reader FCR 5501D Dual Side Reader (Standard Pixel Density Image (High Pixel Density Image Mode) Mode) Predicate Device FCR 9501 FCR 9501HQ 510(k) for Predicate Device K944046 K951373 Classification Class I1, 8§92.1900 Class II, 892.1900 Product Code 90LLZ and 90IXW 90LLZ and 90IXW 510 (k) Fuji Dual Side… | 1995 |
| * | K951373 | Fuji Computed Radiography System FCR9000HQ, FCR9501HQSummary page 1…r FCR 5501D Dual Side Reader (Standard Pixel Density Image (High Pixel Density Image Mode) Mode) Predicate Device FCR 9501 FCR 9501HQ 510(k) for Predicate Device K944046 K951373 Classification Class I1, 8§92.1900 Class II, 892.1900 Product Code 90LLZ and 90IXW 90LLZ and 90IXW 510 (k) Fuji Dual Side Reading… | 1995 |
What descends from it? (82)
See all 823 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 30, 2004 | Not classified | Z-0055-05 | Other | Genital Protector Shield used with Fuji Computed Radiography (FCR) system models 5501D and XU/D1. Model: GP344 may detach from the mounting block and fall during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
The indications for use of the FCR 5501D is the same as the predicate device: the identification, capture, digitization, and processing of diagnostic x-ray images, and associating patient and exam identification with the 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/K993861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993861: Fuji Computed Radiography Dual Side Reading, Both Side Reading, FCR 5501D Dual Side Reader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993861
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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