510(k) · Cleared
Cleared14HK701G-W
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 Oct 18, 2018 as substantially equivalent to K180332 (Lg Electronics, 2018) and 1 other predicate after a 50-day review. Its family tree reaches back 8 generations to 1986. 7 later devices descend from it.
- Decided
- Oct 18, 2018
- Review
- 50 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K862120 (1986). 9 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 7 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 6 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 5 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 4 generations backK123098 Xgeo GC80Samsung Electronics Co., Ltd. · 2013
- 3 generations backK140334 Xgeo GC80Samsung Electronics Co., Ltd. · 2014
- 2 generations backK150165 GC85ASamsung Electronics Co., Ltd. · 2015
- 1 generation backK180332 17HK700G-WLg Electronics · 2018
- This deviceK182348 14HK701G-WLg Electronics.Inc · 2018
- Descendant · cites it directly · 2 of its ownK183286 17HK701G-WLg Electronics.Inc · 2018
- Descendant · cites it directly · 1 of its ownK221394 14HQ701G-BLg Electronics.Inc · 2022
- Descendant · 2 generations on · 1 of its ownK214044 14HQ901G-BLg Electronics.Inc · 2022
- Descendant · 2 generations on · 0 of its ownK223546 14HQ721G-BLg Electronics.Inc · 2023
- Descendant · cites it directly · 0 of its ownK221461 10HQ701G-BLg Electronics.Inc · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K18328617HK701G-WLg Electronics.Inc · 2018 · cites it directly2descendants
- K22139414HQ701G-BLg Electronics.Inc · 2022 · cites it directly1descendant
- K21404414HQ901G-BLg Electronics.Inc · 2022 · 2 generations on1descendant
- K22354614HQ721G-BLg Electronics.Inc · 2023 · 2 generations on0descendants
- K22146110HQ701G-BLg Electronics.Inc · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −7 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −6 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −5 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −4 | K123098 | Xgeo GC80 | Samsung Electronics Co., Ltd. | 2013 | — |
| −3 | K140334 | Xgeo GC80 | Samsung Electronics Co., Ltd. | 2014 | — |
| −2 | K150165 | GC85A | Samsung Electronics Co., Ltd. | 2015 | — |
| −1 | K180332 | 17HK700G-W | Lg Electronics | 2018 | — |
| 0 (this device) | K182348 | 14HK701G-W | Lg Electronics.Inc | 2018 | — |
| +1 | K183286 | 17HK701G-W | Lg Electronics.Inc | 2018 | — |
| +1 | K221394 | 14HQ701G-B | Lg Electronics.Inc | 2022 | — |
| +2 | K214044 | 14HQ901G-B | Lg Electronics.Inc | 2022 | — |
| +2 | K223546 | 14HQ721G-B | Lg Electronics.Inc | 2023 | — |
| +1 | K221461 | 10HQ701G-B | Lg Electronics.Inc | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K180332 | 17HK700G-WSummary page 6…evice(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow; Predicate Device 1 ⚫ 510(k) Number: K180332 ⚫ Applicant: LG Electronics Inc. ⚫ Trade/Device Name: 17HK700G-W ⚫ Common Name:… | 2018 |
| * | K150165 | GC85ASummary page 6…duct MQB Code ⚫ Device Class: II ⚫ 510(k) Review Panel: Radiology Predicate Device 2 ⚫ 510(k) Number: K150165 ⚫ Applicant: Samsung Electronics Co., Ltd. ⚫ Trade/Device Name: S4343-W (of GC85A) ⚫… | 2015 |
What descends from it? (7)
4 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 32 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K183286 (Lg Electronics.Inc, 2018) has gone furthest, with 2 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. 2018, 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?
Flat Panel Digital X-ray Detectors are 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 and not to be used for mammography.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182348: 14HK701G-W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182348
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