510(k) · Cleared
ClearedTOPAZ Mobile DR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DRGEM Corporation · IZL System, X-Ray, Mobile
Cleared on May 19, 2020 as substantially equivalent to K183292 (DRGEM Corporation, 2019) after a 22-day review. Its family tree reaches back 18 generations to 1998. 3 later devices descend from it.
- Decided
- May 19, 2020
- Review
- 22 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 18 generations to K981556 (1998). 58 ancestors in all, the oldest K862120 (1986). 3 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 backK181626 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2018
- 1 generation backK183292 Topaz Mobile DR SystemDRGEM Corporation · 2019
- This deviceK201124 TOPAZ Mobile DR SystemDRGEM Corporation · 2020
- Descendant · cites it directly · 2 of its ownK242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)DRGEM Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK260085 RAYMO Mobile X-ray System (Model: RAYMO)DRGEM Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK251443 PROMODRGEM Corporation · 2025
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 backK181626 Digital Diagnostic Mobile X-ray SystemSamsung Electronics Co., Ltd. · 2018
- 1 generation backK183292 Topaz Mobile DR SystemDRGEM Corporation · 2019
- This deviceK201124 TOPAZ Mobile DR SystemDRGEM Corporation · 2020
Most influential descendants
Showing 3 of 3 · 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 | K181626 | Digital Diagnostic Mobile X-ray System | Samsung Electronics Co., Ltd. | 2018 | — |
| −1 | K183292 | Topaz Mobile DR System | DRGEM Corporation | 2019 | — |
| 0 (this device) | K201124 | TOPAZ Mobile DR System | DRGEM Corporation | 2020 | — |
| +1 | K242015 | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | DRGEM Corporation | 2024 | — |
| +2 | K260085 | RAYMO Mobile X-ray System (Model: RAYMO) | DRGEM Corporation | 2026 | — |
| +2 | K251443 | PROMO | DRGEM Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 IZL? 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 IZL device
- #1 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D…score 19.9 · 19 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 |
|---|---|---|---|
| * | K183292 | Topaz Mobile DR SystemSummary page 4…TE DEVICE The TOPAZ Mobile DR System device is substantially equivalent to: Device Classification Name Mobile X-Ray System 510(K) Number K183292 Device Name Topaz Mobile DR System Applicant DRGEM Corporation… | 2019 |
| † | K161459 | Nexus DRTM Digital X-ray Imaging System (with PaxScan 4336Wv4) | 2016 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242015 | TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) | 2024 | 2 |
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 22 years and passes through 7 companies; a new generation was cleared every 10 months on median.
- 16 of the 58 ancestors have a recall of any class.
- Of its descendants, K242015 (DRGEM Corporation, 2024) has gone furthest, with 2 descendants of its own.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · IZL
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZL
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZL
47in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZL
27in 2025
MAUDE reports naming product code IZL, 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 | 3 | 30 | 7 | 16 |
| 2008 | 4 | 49 | 0 | 27 |
| 2009 | 3 | 125 | 0 | 35 |
| 2010 | 3 | 65 | 4 | 75 |
| 2011 | 6 | 66 | 6 | 118 |
| 2012 | 3 | 83 | 5 | 24 |
| 2013 | 0 | — | 10 | 17 |
| 2014 | 7 | 104 | 4 | 51 |
| 2015 | 4 | 88 | 4 | 30 |
| 2016 | 6 | 47 | 0 | 33 |
| 2017 | 7 | 45 | 0 | 35 |
| 2018 | 8 | 47 | 0 | 27 |
| 2019 | 9 | 33 | 2 | 40 |
| 2020 | 9 | 43 | 1 | 48 |
| 2021 | 13 | 48 | 0 | 47 |
| 2022 | 16 | 89 | 1 | 32 |
| 2023 | 3 | 55 | 6 | 77 |
| 2024 | 9 | 159 | 5 | 39 |
| 2025 | 11 | 153 | 47 | 27 |
| 2026 | 6 | 157 | 5 | — |
What is it indicated for?
The TOPAZ Mobile DR System, is a mobile X-ray imaging system, for the purpose of acquiring X-ray images of the desired parts of a patient’s anatomy.
This device is not intended for mammography, bone density, fluoroscopy and angiography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201124 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201124: TOPAZ Mobile DR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201124
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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