510(k) · Cleared
ClearedATAL 9
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atlaim Corporation · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Nov 10, 2015 as substantially equivalent to K113812 (Atlaim, 2012) after a 99-day review. Its family tree reaches back 3 generations to 2007. 5 later devices descend from it.
- Decided
- Nov 10, 2015
- Review
- 99 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K063710 (2007). 5 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 backK113812 ATAL-8Atlaim · 2012
- This deviceK152151 ATAL 9Atlaim Corporation · 2015
- Descendant · cites it directly · 2 of its ownK180976 PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor…Pixxgen Corporation · 2018
- Descendant · 2 generations on · 1 of its ownK182533 PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor…Pixxgen Corporation · 2018
- Descendant · cites it directly · 1 of its ownK170480 Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK212105 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK211108 Prudent 1717, Prudent 1417, Prudent 1212Pixxgen Corporation · 2021
Most influential descendants
Showing 5 of 5 · See all- K180976PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor PanelsPixxgen Corporation · 2018 · cites it directly2descendants
- K182533PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor PanelsPixxgen Corporation · 2018 · 2 generations on1descendant
- K170480Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd. · 2017 · cites it directly1descendant
- K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd. · 2021 · 2 generations on0descendants
- K211108Prudent 1717, Prudent 1417, Prudent 1212Pixxgen Corporation · 2021 · 3 generations on0descendants
View 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 | K113812 | ATAL-8 | Atlaim | 2012 | — |
| 0 (this device) | K152151 | ATAL 9 | Atlaim Corporation | 2015 | — |
| +1 | K180976 | PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels | Pixxgen Corporation | 2018 | — |
| +2 | K182533 | PIXX 1717; PIXX 1417; PIXX 1212; Digital Diagnostic X-ray Receptor Panels | Pixxgen Corporation | 2018 | — |
| +1 | K170480 | Models 3543A, 4343A, 2929A and A843B | Shanghai PZ Medical Technolgoy Co., Ltd. | 2017 | — |
| +2 | K212105 | 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF | Pzmedical Technology Co., Ltd. | 2021 | — |
| +3 | K211108 | Prudent 1717, Prudent 1417, Prudent 1212 | Pixxgen Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 2 | 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 |
|---|---|---|---|
| * | K113812 | ATAL-8Summary page 4…al X-Ray Receptor Panel Product Code: MQB Device Class/Regulation Number: Class II per regulation 892.1680 2. Equivalent legally marketed device: ATAL 8, ATAL 8c, K113812, Atlaim Corporation. Classification Name: Stationary X-ray System Common/Usual Name: Digital X-Ray Receptor Panel Produc… | 2012 |
What descends from it? (5)
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 8 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K180976 (Pixxgen Corporation, 2018) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K113812.
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. 2015, 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 9 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/K152151 · printed Nov 3, 2026
Cite this page
510(k) Report. “K152151: ATAL 9.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K152151
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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