510(k) · Cleared
Recalled · 2004Fuji Speed Suite, Fuji Speed Sute Phase II
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 Dec 20, 2001 as substantially equivalent to K971452 (Siemens Medical Solutions USA, Inc., 1997) and 3 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1981. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 20, 2001
- Review
- 85 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 2 generations to K803130 (1981). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 1 generation backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- This deviceK013218 Fuji Speed Suite, Fuji Speed Sute Phase IIFujifilm Medical System U.S.A., Inc. · 2001
- Descendant · cites it directly · 0 of its ownK091631 Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K091631Accessnet, Accessmed, Accessrad, MedviewAspyra, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −1 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| 0 (this device) | K013218 | Fuji Speed Suite, Fuji Speed Sute Phase II | Fujifilm Medical System U.S.A., Inc. | 2001 | — |
| +1 | K091631 | Accessnet, Accessmed, Accessrad, Medview | Aspyra, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (4)
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 |
|---|---|---|---|
| * | K971452 | Multix Top/Pro Radiographic X-Ray TableSummary page 1…on names are: Stationary x-ray system Predicate Device {21 CFR 807.92(a)(3)] Fuji identifies the predicate devices as follows: Siemens Multix TOP/PRO Radiographic Table K971452 Siemens Multix Compact K bucky table K001201 Fuji FCR 5501D K 993861 Fuji HI-C654 Multimodality Workstation K972256 Fuji ID-T741… | 1997 |
| * | K001201 | Multix Compact K and Multix L Radiographic X-Ray SystemsSummary page 1…te Device {21 CFR 807.92(a)(3)] Fuji identifies the predicate devices as follows: Siemens Multix TOP/PRO Radiographic Table K971452 Siemens Multix Compact K bucky table K001201 Fuji FCR 5501D K 993861 Fuji HI-C654 Multimodality Workstation K972256 Fuji ID-T741 ID terminal ' K993861 Description of the Dev… | 2000 |
| * | K993861 | Fuji Computed Radiography Dual Side Reading, Both Side Reading, FCR 5501D Dual Side ReaderSummary page 1…2(a)(3)] Fuji identifies the predicate devices as follows: Siemens Multix TOP/PRO Radiographic Table K971452 Siemens Multix Compact K bucky table K001201 Fuji FCR 5501D K 993861 Fuji HI-C654 Multimodality Workstation K972256 Fuji ID-T741 ID terminal ' K993861 Description of the Device {21 CFR 807.92(a)(4)… | 2000 |
| * | K972256 | FCR Fuji Computed Radiography DMS CRT Image Console HI-C654 (for Networks)Summary page 1…s follows: Siemens Multix TOP/PRO Radiographic Table K971452 Siemens Multix Compact K bucky table K001201 Fuji FCR 5501D K 993861 Fuji HI-C654 Multimodality Workstation K972256 Fuji ID-T741 ID terminal ' K993861 Description of the Device {21 CFR 807.92(a)(4)] Summary of the function of the device and it… | 1997 |
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 |
|---|---|---|---|
| K091631 | Accessnet, Accessmed, Accessrad, Medview | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 5, 2004 | Not classified | Z-0993-04 | Other | Software: Incorrect measurement of objects within a CR image |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 16.3 years on median.
- 5 of the 9 ancestors have a recall of any class.
- Of its descendants, K091631 (Aspyra, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K971452.
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 for the FUJI SPEED SUITE is the same as the predicate device: radiographic exposures of the entire body specifically the skull, spinal column, chest, and abdomen, as well as extremities, 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/K013218 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013218: Fuji Speed Suite, Fuji Speed Sute Phase II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013218
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026