510(k) · Cleared
ClearedModels 3543A, 4343A, 2929A and A843B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai PZ Medical Technolgoy Co., Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jul 7, 2017 as substantially equivalent to K152151 (Atlaim Corporation, 2015) and 2 other predicates after a 141-day review. Its family tree reaches back 11 generations to 1998. 1 later device descends from it.
- Decided
- Jul 7, 2017
- Review
- 141 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K981556 (1998). 44 ancestors in all, the oldest K803130 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 7 generations between
- 3 generations backK123644 Vizion + DRViztek, LLC · 2013
- 2 generations backK152279 ViZion DR + WirelessViztek, LLC · 2015
- 1 generation backK161730 Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016
- This deviceK170480 Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK212105 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd. · 2021
Show all 11 generations
- Root · 11 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 10 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 9 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 8 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 7 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 6 generations backK082604 Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc. · 2008
- 5 generations backK102123 Vizion DRViztek, Inc. · 2011
- 4 generations backK112661 Vizion DRViztek, LLC · 2011
- 3 generations backK123644 Vizion + DRViztek, LLC · 2013
- 2 generations backK152279 ViZion DR + WirelessViztek, LLC · 2015
- 1 generation backK161730 Wireless Digital Flat Panel DetectorIray Technology (Shanghai), Ltd. · 2016
- This deviceK170480 Models 3543A, 4343A, 2929A and A843BShanghai PZ Medical Technolgoy Co., Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K2121056543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZFPzmedical Technology Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −10 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −9 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −8 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −7 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −6 | K082604 | Viztek DR, Models: DR1000, DR3000, DR4000 | Viztek, Inc. | 2008 | — |
| −5 | K102123 | Vizion DR | Viztek, Inc. | 2011 | — |
| −4 | K112661 | Vizion DR | Viztek, LLC | 2011 | — |
| −3 | K123644 | Vizion + DR | Viztek, LLC | 2013 | — |
| −2 | K152279 | ViZion DR + Wireless | Viztek, LLC | 2015 | — |
| −1 | K161730 | Wireless Digital Flat Panel Detector | Iray Technology (Shanghai), Ltd. | 2016 | — |
| 0 (this device) | K170480 | Models 3543A, 4343A, 2929A and A843B | Shanghai PZ Medical Technolgoy Co., Ltd. | 2017 | — |
| +1 | K212105 | 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF | Pzmedical Technology Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (3)
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 |
|---|---|---|---|
| * | K152151 | ATAL 9Summary page 4…Solid State X-Ray Imager (Flat Panel/Digital Imager) Classification name: Stationary X-Ray system, 892.1680, code MQB Predicate devices: Atlaim’s model ATAL 9 – K152151 Stationary X-Ray system, 892.1680, code MQB IRAY model 1417 – K161730… | 2015 |
| * | K161730 | Wireless Digital Flat Panel DetectorSummary page 4…ode MQB Predicate devices: Atlaim’s model ATAL 9 – K152151 Stationary X-Ray system, 892.1680, code MQB IRAY model 1417 – K161730 Stationary X-Ray system, 892.1680, code MQB CareRay model Care view 1500C & 1500L –… | 2016 |
| * | K153058 | CareView 1500C/ CareView 1500L X-ray Flat Panel DetectorsSummary page 4…IRAY model 1417 – K161730 Stationary X-Ray system, 892.1680, code MQB CareRay model Care view 1500C & 1500L – K153058 Stationary X-Ray system, 892.1680, code MQB Description: Our device is used in medical x-ray imag… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212105 | 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF | 2021 | 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?
- The line of descent spans 19 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 11 of the 44 ancestors have a recall of any class.
- Of its descendants, K212105 (Pzmedical Technology Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K152151.
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. 2017, 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?
Model#'s 3543A, 4343A, 2929A and A843B; Solid State X-ray Imager (Flat Panel/Digital Imager) are indicated for use in generating radiographic images of human anatomy. They are intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding dental, fluoroscopic, angiographic, and mammographic applications. As prescribed by a licensed physician
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170480: Models 3543A, 4343A, 2929A and A843B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170480
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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