510(k) · Cleared
ClearedScanx D5000 Series Scanner Model: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Air Techniques, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Aug 3, 2010 as substantially equivalent to K031198 (Air Techniques, Inc., 2003) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Aug 3, 2010
- Review
- 88 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K013893 (2002). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK013893 SCANXAir Techniques, Inc. · 2002
- This deviceK101289 Scanx D5000 Series Scanner Model: D5000-F, D5000-FB, D5000-FVB…Air Techniques, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013893 | SCANX | Air Techniques, Inc. | 2002 | — |
| 0 (this device) | K101289 | Scanx D5000 Series Scanner Model: D5000-F, D5000-FB, D5000-FVB, D5000-Q… | Air Techniques, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031198 | SCANX 10Summary page 1…name: Solid State X-Ray Imaging System, 892.1630 4. Predicate Device lnfoi’mation: The legally marketed devices to which equivalence is being claimed are: ScanX 10- 510K 031198 Air Techniques, Inc., Melville, New York USA ScanX Scanner, 510K 013893 Air Techniques, inc., Melville, New York USA Portable X… | 2003 |
| * | K013893 | SCANXSummary page 1…oi’mation: The legally marketed devices to which equivalence is being claimed are: ScanX 10- 510K 031198 Air Techniques, Inc., Melville, New York USA ScanX Scanner, 510K 013893 Air Techniques, inc., Melville, New York USA Portable X-Ray System : AnyRay — 510K 081889 Giheung-Gu, Yongin-Si, Gyeonggi-Do, Ko… | 2002 |
| Kept off the family tree | K081898 | FDA’s K081898 is Expedium Spine System Our OCR of the scanned summary read K081898, FDA’s number for Expedium Spine System (Depuy Spine, Inc.), which shares no word with the summary’s name for the device, “Portable X-Ray System “Any Ray””, apart from generic ones like “system”. Kept off the family tree. Summary page 2…lithium battery used in the ScanX D5000-FB, D5000-FVB, and D5000-QB battery operated scanners is equivalent to a predicate Portable X-Ray System “Any Ray”, 510(K) number K081898. The indications for use and basic overall specifications, operational characteristics, and materials used for the rechargeable b… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K031198.
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. 2010, this device’s year, is highlighted.
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 ScanX D5000 series scanners, with and without battery option are devices that read photostimulable phosphor plates that have been exposed in place of x-ray film and allow those images to be displayed on a personal computer display and stored for later recovery in a computer’s memory. It will be used by physicians, dentists, veterinarians, and authorized medical auxiliary personnel for this purpose. These scanners are not intended to be used for mammographic 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/K101289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101289: Scanx D5000 Series Scanner Model: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101289
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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