510(k) · Cleared
ClearedADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H&abyz Co., Ltd. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Nov 15, 2021 as substantially equivalent to K203188 (H&abyz Co., Ltd., 2021) after a 14-day review. Its family tree reaches back 18 generations to 1998. 2 later devices descend from it.
- Decided
- Nov 15, 2021
- Review
- 14 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K981556 (1998). 84 ancestors in all, the oldest K803130 (1981). 2 later devices descend from it, 1 citing it directly.
- Root · 18 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 14 generations between
- 3 generations backK180543 GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd. · 2018
- 2 generations backK181631 GR40CWSamsung Electronics Co., Ltd. · 2018
- 1 generation backK203188 ADDH&abyz Co., Ltd. · 2021
- This deviceK213497 ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK223930 A1417MCW/A1717MCW/F1417MCWH&abyz Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK241346 IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)Aspen Imaging Healthcare, Inc. · 2024
Show all 18 generations
- Root · 18 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 17 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 16 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 15 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 14 generations backK060433 Digital Radiography Cxdi-50CCanon, Inc. · 2006
- 13 generations backK091545 Digital Radiography Cxdi-60CCanon, Inc. · 2009
- 12 generations backK102012 Digital RadiographyCanon Inc. -Medical Equipment Group · 2010 · Recalled
- 11 generations backK103596 Wireless/Wired FDR D-Evo Flat Panel DetectorFujifilm Medical Systems U.S.A, Inc. · 2011
- 10 generations backK111548 Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600…Fujifilm Medical System U.S.A., Inc. · 2011
- 9 generations backK132509 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2013
- 8 generations backK141765 FDR D-Evo Flat Panel Detector SystemFujifilm Medical Systems U.S.A, Inc. · 2014
- 7 generations backK160997 GC85ASamsung Electronics Co., Ltd. · 2016
- 6 generations backK162278 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2016
- 5 generations backK171119 GM85Samsung Electronics Co., Ltd. · 2017 · Recalled
- 4 generations backK173828 GU60A & GU60A-65Samsung Electronics Co., Ltd. · 2018
- 3 generations backK180543 GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85Samsung Electronics Co., Ltd. · 2018
- 2 generations backK181631 GR40CWSamsung Electronics Co., Ltd. · 2018
- 1 generation backK203188 ADDH&abyz Co., Ltd. · 2021
- This deviceK213497 ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW)H&abyz Co., Ltd. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −17 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −16 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −15 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −14 | K060433 | Digital Radiography Cxdi-50C | Canon, Inc. | 2006 | — |
| −13 | K091545 | Digital Radiography Cxdi-60C | Canon, Inc. | 2009 | — |
| −12 | K102012 | Digital Radiography | Canon Inc. -Medical Equipment Group | 2010 | 1 |
| −11 | K103596 | Wireless/Wired FDR D-Evo Flat Panel Detector | Fujifilm Medical Systems U.S.A, Inc. | 2011 | — |
| −10 | K111548 | Wireless/Wired FDR D-Evo Flat Pancel Detector System Model DR-ID600 W/DR-ID611SE | Fujifilm Medical System U.S.A., Inc. | 2011 | — |
| −9 | K132509 | FDR D-Evo Flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | 2013 | — |
| −8 | K141765 | FDR D-Evo Flat Panel Detector System | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
| −7 | K160997 | GC85A | Samsung Electronics Co., Ltd. | 2016 | — |
| −6 | K162278 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | 2016 | — |
| −5 | K171119 | GM85 | Samsung Electronics Co., Ltd. | 2017 | 1 |
| −4 | K173828 | GU60A & GU60A-65 | Samsung Electronics Co., Ltd. | 2018 | — |
| −3 | K180543 | GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 | Samsung Electronics Co., Ltd. | 2018 | — |
| −2 | K181631 | GR40CW | Samsung Electronics Co., Ltd. | 2018 | — |
| −1 | K203188 | ADD | H&abyz Co., Ltd. | 2021 | — |
| 0 (this device) | K213497 | ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) | H&abyz Co., Ltd. | 2021 | — |
| +1 | K223930 | A1417MCW/A1717MCW/F1417MCW | H&abyz Co., Ltd. | 2023 | — |
| +2 | K241346 | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) | Aspen Imaging Healthcare, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K203188 | ADDSummary page 6…te Device(s) [21 CFR 807.92(a)(3)] The identified predicate device within this submission are shown as follow; Predicate Device 510(k) Number: K203188 Applicant: H&abyz Co., Ltd. Trade/Device Name: ADD Common Name: Dig… | 2021 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223930 | A1417MCW/A1717MCW/F1417MCW | 2023 | 1 |
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 23 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 30 of the 84 ancestors have a recall of any class.
- Of its descendants, K223930 (H&abyz Co., Ltd., 2023) has gone furthest, with 1 descendant 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. 2021, 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?
ADD (Digital Flat Panel X-Ray Detector) is indicated for digital imaging solution designed for providing general
radiographic diagnosis of human anatomy targeting both adult and children. It is intended to replace film based
radiographic diagnostic systems. 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/K213497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K213497: ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K213497
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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