510(k) · Cleared
Cleared14HQ721G-B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lg Electronics.Inc · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jan 27, 2023 as substantially equivalent to K221394 (Lg Electronics.Inc, 2022) after a 63-day review. Its family tree reaches back 10 generations to 1986.
- Decided
- Jan 27, 2023
- Review
- 63 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K862120 (1986). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 6 generations between
- 3 generations backK180332 17HK700G-WLg Electronics · 2018
- 2 generations backK182348 14HK701G-WLg Electronics.Inc · 2018
- 1 generation backK221394 14HQ701G-BLg Electronics.Inc · 2022
- This deviceK223546 14HQ721G-BLg Electronics.Inc · 2023
Show all 10 generations
- Root · 10 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 9 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 8 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 7 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 6 generations backK123098 Xgeo GC80Samsung Electronics Co., Ltd. · 2013
- 5 generations backK140334 Xgeo GC80Samsung Electronics Co., Ltd. · 2014
- 4 generations backK150165 GC85ASamsung Electronics Co., Ltd. · 2015
- 3 generations backK180332 17HK700G-WLg Electronics · 2018
- 2 generations backK182348 14HK701G-WLg Electronics.Inc · 2018
- 1 generation backK221394 14HQ701G-BLg Electronics.Inc · 2022
- This deviceK223546 14HQ721G-BLg Electronics.Inc · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −9 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −8 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −7 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −6 | K123098 | Xgeo GC80 | Samsung Electronics Co., Ltd. | 2013 | — |
| −5 | K140334 | Xgeo GC80 | Samsung Electronics Co., Ltd. | 2014 | — |
| −4 | K150165 | GC85A | Samsung Electronics Co., Ltd. | 2015 | — |
| −3 | K180332 | 17HK700G-W | Lg Electronics | 2018 | — |
| −2 | K182348 | 14HK701G-W | Lg Electronics.Inc | 2018 | — |
| −1 | K221394 | 14HQ701G-B | Lg Electronics.Inc | 2022 | — |
| 0 (this device) | K223546 | 14HQ721G-B | Lg Electronics.Inc | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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 |
|---|---|---|---|
| * | K221394 | 14HQ701G-BSummary page 5…ice(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follows; Predicate Device 510(k) Number: K221394 Applicant: LG Electronics Inc. Trade/Device Name: 14HQ701G-B Common Name:… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 37 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 11 ancestors have a recall of any class.
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. 2023, 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 Flat Panel Digital X-ray Detector 14HQ721G-B is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223546 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223546: 14HQ721G-B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223546
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