510(k) · Cleared
ClearedFlaatz 560
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 Oct 4, 2011 as substantially equivalent to K102284 (Medicatech USA, 2011) after a 119-day review. Its family tree reaches back 3 generations to 2007. 2 later devices descend from it.
- Decided
- Oct 4, 2011
- Review
- 119 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K063710 (2007). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK063710 Saturn 9000New Medical Co., Ltd. · 2007
- 2 generations backK080064 Flaatz 750Drtech Corp. · 2008
- 1 generation backK102284 Krystalrad 560 (Flaatz 560)Medicatech USA · 2011
- This deviceK111583 Flaatz 560Drtech Corp. · 2011
- Descendant · cites it directly · 0 of its ownK132842 Flaatz 600 Series (Flaatz 600/601)Drtech Corp. · 2014
- Descendant · cites it directly · 0 of its ownK113855 Panorad, Panorad SLImix Adr Finland OY · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K063710 | Saturn 9000 | New Medical Co., Ltd. | 2007 | — |
| −2 | K080064 | Flaatz 750 | Drtech Corp. | 2008 | — |
| −1 | K102284 | Krystalrad 560 (Flaatz 560) | Medicatech USA | 2011 | — |
| 0 (this device) | K111583 | Flaatz 560 | Drtech Corp. | 2011 | — |
| +1 | K132842 | Flaatz 600 Series (Flaatz 600/601) | Drtech Corp. | 2014 | — |
| +1 | K113855 | Panorad, Panorad SL | Imix Adr Finland OY | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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? (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 |
|---|---|---|---|
| * | K102284 | Krystalrad 560 (Flaatz 560)Summary page 1…MOB 8. Predicate Device KRYSTALRAD 560 (FLAATZ 560) SYSTEM Medicatech USA, 510(k) No.: K102284 9. Device Description The FLAATZ 560 is a radiographic image acquisition device. It is a fully integrated image capture a… | 2011 |
| † | K091797 | TSRH Spinal System | 2010 |
What descends from it? (2)
2 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?
- The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K132842 (Drtech Corp., 2014) has gone furthest, with 0 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. 2011, 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 560 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 as stated in the FDA summary.
https://510kreport.com/device/K111583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111583: Flaatz 560.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111583
Report an extraction error
Are you the manufacturer?
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