510(k) · Cleared
ClearedFuji Computed Radiography (FCR) Velocity Image 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 Nov 26, 2003 as substantially equivalent to K951373 (Fujifilm Medical System U.S.A., Inc., 1995) after a 14-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Nov 26, 2003
- Review
- 14 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951373 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK951373 Fuji Computed Radiography System FCR9000HQ, FCR9501HQFujifilm Medical System U.S.A., Inc. · 1995
- This deviceK033561 Fuji Computed Radiography (FCR) Velocity Image ReaderFujifilm Medical System U.S.A., Inc. · 2003
- Descendant · cites it directly · 0 of its ownK073650 Fujifilm Unity Speedsuite, Model CR-IR 371Fujifilm Medical Systems U.S.A, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K073650Fujifilm Unity Speedsuite, Model CR-IR 371Fujifilm Medical Systems U.S.A, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951373 | Fuji Computed Radiography System FCR9000HQ, FCR9501HQ | Fujifilm Medical System U.S.A., Inc. | 1995 | — |
| 0 (this device) | K033561 | Fuji Computed Radiography (FCR) Velocity Image Reader | Fujifilm Medical System U.S.A., Inc. | 2003 | — |
| +1 | K073650 | Fujifilm Unity Speedsuite, Model CR-IR 371 | Fujifilm Medical Systems U.S.A, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 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? (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 |
|---|---|---|---|
| * | K951373 | Fuji Computed Radiography System FCR9000HQ, FCR9501HQSummary page 2…comparable and substantially equivalent to the FCR 9501-HQ Image Reader manufactured by Fuji. FCR 9501-HQ has been granted a 510(k) clearance. Refer to accession number K951373. [ PARAMETER | FUJLFCRVELOCITYU | FUJI FCR 9501HQ Image Recording - : ' Patient Identification Digital Data (from Console) Digi… | 1995 |
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 |
|---|---|---|---|
| K073650 | Fujifilm Unity Speedsuite, Model CR-IR 371 | 2008 | 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?
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 Fuji Computed Radiography (FCR) Velocity Image Reader with Image Plate (IP) reading is 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/K033561 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033561: Fuji Computed Radiography (FCR) Velocity Image Reader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033561
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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