510(k) · Cleared
ClearedSaturn 9000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Medical Co., Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jul 16, 2007 after a 214-day review. The FDA summary names its predicate without a number. 73 later devices descend from it.
- Decided
- Jul 16, 2007
- Review
- 214 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 0
73 later devices descend from it, 4 citing it directly.
- This deviceK063710 Saturn 9000New Medical Co., Ltd. · 2007
- Descendant · cites it directly · 69 of its ownK080064 Flaatz 750Drtech Corp. · 2008
- Descendant · 2 generations on · 41 of its ownK113812 ATAL-8Atlaim · 2012
- Descendant · 3 generations on · 33 of its ownK123644 Vizion + DRViztek, LLC · 2013
- Descendant · 4 generations on · 27 of its ownK152279 ViZion DR + WirelessViztek, LLC · 2015
- Descendant · 5 generations on · 24 of its ownK161730 Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 73 · See all- K080064Flaatz 750Drtech Corp. · 2008 · cites it directly69descendants
- K113812ATAL-8Atlaim · 2012 · 2 generations on41descendants
- K123644Vizion + DRViztek, LLC · 2013 · 3 generations on33descendants
- K152279ViZion DR + WirelessViztek, LLC · 2015 · 4 generations on27descendants
- K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016 · 5 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063710 | Saturn 9000 | New Medical Co., Ltd. | 2007 | — |
| +1 | K080064 | Flaatz 750 | Drtech Corp. | 2008 | — |
| +2 | K113812 | ATAL-8 | Atlaim | 2012 | — |
| +3 | K123644 | Vizion + DR | Viztek, LLC | 2013 | — |
| +4 | K152279 | ViZion DR + Wireless | Viztek, LLC | 2015 | — |
| +5 | K161730 | Wireless Digital Flat Panel Detector | Iray Technology (Shanghai), Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 8 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 4 | 0 |
| 2021 | 7 | 0 |
| 2022 | 7 | 0 |
| 2023 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | — | StingRay Named without a submission number |
What descends from it? (73)
See all 734 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K080064 (Drtech Corp., 2008) has gone furthest, with 69 descendants of its own.
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. 2007, 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 Satum 9000 system generates digital X-ray images that can be used for general X-ray system not for Mammography. The Saturn 9000 system can interface to traditional X-ray generator and get digital X-ray image. The Saturn 9000 is intended to be used in same clinical application as traditional film-screen based general radiography system.
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/K063710 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063710: Saturn 9000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063710
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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