510(k) · Cleared
ClearedFlaatz 750
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drtech Corp. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jan 23, 2008 as substantially equivalent to K063710 (New Medical Co., Ltd., 2007) after a 13-day review. Its family tree reaches back 1 generation to 2007. 69 later devices descend from it.
- Decided
- Jan 23, 2008
- Review
- 13 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063710 (2007). 69 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK063710 Saturn 9000New Medical Co., Ltd. · 2007
- This deviceK080064 Flaatz 750Drtech Corp. · 2008
- Descendant · cites it directly · 41 of its ownK113812 ATAL-8Atlaim · 2012
- Descendant · 2 generations on · 33 of its ownK123644 Vizion + DRViztek, LLC · 2013
- Descendant · 3 generations on · 27 of its ownK152279 ViZion DR + WirelessViztek, LLC · 2015
- Descendant · 4 generations on · 24 of its ownK161730 Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016
- Descendant · 5 generations on · 18 of its ownK182551 Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2018
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K113812ATAL-8Atlaim · 2012 · cites it directly41descendants
- K123644Vizion + DRViztek, LLC · 2013 · 2 generations on33descendants
- K152279ViZion DR + WirelessViztek, LLC · 2015 · 3 generations on27descendants
- K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016 · 4 generations on24descendants
- K182551Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2018 · 5 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063710 | Saturn 9000 | New Medical Co., Ltd. | 2007 | — |
| 0 (this device) | K080064 | Flaatz 750 | Drtech Corp. | 2008 | — |
| +1 | K113812 | ATAL-8 | Atlaim | 2012 | — |
| +2 | K123644 | Vizion + DR | Viztek, LLC | 2013 | — |
| +3 | K152279 | ViZion DR + Wireless | Viztek, LLC | 2015 | — |
| +4 | K161730 | Wireless Digital Flat Panel Detector | Iray Technology (Shanghai), Ltd. | 2016 | — |
| +5 | K182551 | Wireless Digital Flat Panel Detector | Iray Technology Taicang, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 7 | 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 510(k) statement (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 |
|---|---|---|---|
| * | K063710 | Saturn 9000 Our OCR of the scanned summary read K083710, FDA’s number for Retractor Lite (Thomas Surgical Instruments, Inc.), decided Feb 23, 2009, after this device. Corrected to the only number one digit away in this product code whose FDA name shares the summary’s words. | 2007 |
What descends from it? (69)
See all 698 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113812 | ATAL-8 | 2012 | 41 |
| K080582 | Medicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FA | 2008 | 16 |
| K102284 | Krystalrad 560 (Flaatz 560) | 2011 | 3 |
| K083640 | Digital X-Ray Imaging System, Model: CXD-DR80D | 2009 | 2 |
| K113855 | Panorad, Panorad SL | 2012 | 0 |
| K111655 | Flaatz 760 | 2011 | 0 |
| K102474 | Flaatz 750E | 2011 | 0 |
| K102285 | Krystalrad (ATAL8) | 2011 | 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. 2008, 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 FLAATZ 750 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K080064 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080064: Flaatz 750.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080064
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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