510(k) · Cleared
ClearedATAL-8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atlaim · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on May 3, 2012 as substantially equivalent to K080064 (Drtech Corp., 2008) after a 132-day review. Its family tree reaches back 2 generations to 2007. 41 later devices descend from it.
- Decided
- May 3, 2012
- Review
- 132 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K063710 (2007). 41 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK063710 Saturn 9000New Medical Co., Ltd. · 2007
- 1 generation backK080064 Flaatz 750Drtech Corp. · 2008
- This deviceK113812 ATAL-8Atlaim · 2012
- Descendant · cites it directly · 33 of its ownK123644 Vizion + DRViztek, LLC · 2013
- Descendant · 2 generations on · 27 of its ownK152279 ViZion DR + WirelessViztek, LLC · 2015
- Descendant · 3 generations on · 24 of its ownK161730 Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016
- Descendant · 4 generations on · 18 of its ownK182551 Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2018
- Descendant · 5 generations on · 9 of its ownK183713 Wireless Digital Flat DetectorIray Technology Taicang, Ltd. · 2019
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K123644Vizion + DRViztek, LLC · 2013 · cites it directly33descendants
- K152279ViZion DR + WirelessViztek, LLC · 2015 · 2 generations on27descendants
- K161730Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016 · 3 generations on24descendants
- K182551Wireless Digital Flat Panel DetectorIray Technology Taicang, Ltd. · 2018 · 4 generations on18descendants
- K183713Wireless Digital Flat DetectorIray Technology Taicang, Ltd. · 2019 · 5 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K063710 | Saturn 9000 | New Medical Co., Ltd. | 2007 | — |
| −1 | K080064 | Flaatz 750 | Drtech Corp. | 2008 | — |
| 0 (this device) | K113812 | ATAL-8 | Atlaim | 2012 | — |
| +1 | K123644 | Vizion + DR | Viztek, LLC | 2013 | — |
| +2 | K152279 | ViZion DR + Wireless | Viztek, LLC | 2015 | — |
| +3 | K161730 | Wireless Digital Flat Panel Detector | Iray Technology (Shanghai), Ltd. | 2016 | — |
| +4 | K182551 | Wireless Digital Flat Panel Detector | Iray Technology Taicang, Ltd. | 2018 | — |
| +5 | K183713 | Wireless Digital Flat Detector | Iray Technology Taicang, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 6 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K080064 | Flaatz 750Summary page 1…____ MQB Predicate device: DRTech FLAATZ 750 K080064 The ATAL 8 and ATAL BC are flat-panel type digital X-ray detectors that captu… | 2008 |
What descends from it? (41)
See all 414 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 5 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K123644 (Viztek, LLC, 2013) has gone furthest, with 33 descendants of its own.
- 7 other devices also cite its predicate K080064.
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. 2012, 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 ATAL 8 and ATAL 8c is indicated for use in general 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/K113812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113812: ATAL-8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113812
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