510(k) · Cleared
Recalled · Class II · 2013Thorax FD and Multix FD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Apr 21, 1999 as substantially equivalent to K924459 (Siemens Medical Solutions USA, Inc., 1992) and 1 other predicate after a 181-day review. Its family tree reaches back 2 generations to 1981. 187 later devices descend from it. It has been recalled once.
- Decided
- Apr 21, 1999
- Review
- 181 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K803130 (1981). 4 ancestors in all. 187 later devices descend from it, 4 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 deviceK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999
- Descendant · cites it directly · 103 of its ownK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- Descendant · cites it directly · 81 of its ownK013826 Axiom Aristos FX (Multi Purpose Radiography System)Siemens Medical Systems, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 80 of its ownK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 78 of its ownK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 78 of its ownK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
Showing 5 of 187 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 187 · See all- K992794Stingray DR, Model 1Infimed, Inc. · 1999 · cites it directly103descendants
- K013826Axiom Aristos FX (Multi Purpose Radiography System)Siemens Medical Systems, Inc. · 2002 · cites it directly81descendants
- K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · 2 generations on80descendants
- K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · 3 generations on78descendants
- K024147Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003 · 2 generations on78descendants
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) | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | — |
| +1 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| +1 | K013826 | Axiom Aristos FX (Multi Purpose Radiography System) | Siemens Medical Systems, Inc. | 2002 | 8 |
| +2 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| +3 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| +2 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 8 | 0 |
| 2011 | 9 | 0 |
| 2012 | 7 | 0 |
| 2013 | 11 | 0 |
| 2014 | 12 | 0 |
| 2015 | 12 | 0 |
| 2016 | 13 | 0 |
| 2017 | 10 | 0 |
| 2018 | 8 | 0 |
| 2019 | 14 | 0 |
| 2020 | 12 | 0 |
| 2021 | 14 | 0 |
| 2022 | 9 | 0 |
| 2023 | 7 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 7 | 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? (3)
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 |
|---|---|---|---|
| * | K924459 | Digiscan 2Summary page 2…ng SIEMENS Medical Systems devices: “SIEMENS © | SystemType - . | FDA Clearance | FDA Clearance DeviceName | . 0 = o oo ’ Number | Date DIGISCAN 2 Phosphor Plate System K924459 12/17/92 THORAMAT Vertical Chest X-ray System | Pre-Ammendment | Pre-Ammendment Multix TOP/PRO Stationary X-ray System K971452 5/… | 1992 |
| * | K971452 | Multix Top/Pro Radiographic X-Ray TableSummary page 2…er | Date DIGISCAN 2 Phosphor Plate System K924459 12/17/92 THORAMAT Vertical Chest X-ray System | Pre-Ammendment | Pre-Ammendment Multix TOP/PRO Stationary X-ray System K971452 5/14/97 4. Device Description: The SIEMENS Flat Panel Detector is a scintillator-photodetector device. The Flat Panel Detector i… | 1997 |
| * | — | THORAMAT Vertical Chest X-ray System Named without a submission number |
What descends from it? (187)
See all 1874 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 |
|---|---|---|---|---|
| Jun 5, 2013 | Class II | Z-1795-2013 | Device Design | Siemens issued a Field Safety Notice about the potential hazard to patients or operators when using the function "table top float" of the AXIOM Aristos MX. When repositioning a patient lying on the table top and releasing the table top… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 16.3 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K992794 (Infimed, Inc., 1999) has gone furthest, with 103 descendants of its own.
- 2 other devices also cite its predicate K924459.
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 SIEMENS Flat Panel Detector, in both the THORAX FD and the MULTIX FD systems, allows acquisition of x-ray exposures without the use of conventional film/screen systems. The THORAX FD system is a stand alone automated chest unit, while the MULTIX FD is a universal radiographic x-ray system. The MULTIX FD and THORAX FD both allow radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions.
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/K983732 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983732: Thorax FD and Multix FD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983732
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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