510(k) · Cleared
ClearedQuantum/ Canon Cxdi Integration System, Model QG-Dig-Cxdi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantum Medical Imaging, LLC · LLZ System, Image Processing, Radiological
Cleared on Jul 16, 2008 as substantially equivalent to K011486 (Quantum Medical Imaging, LLC, 2001) and 3 other predicates after a 106-day review. Its family tree reaches back 6 generations to 1991. 4 later devices descend from it.
- Decided
- Jul 16, 2008
- Review
- 106 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K904519 (1991). 20 ancestors in all, the oldest K803130 (1981). 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 5 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 4 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 3 generations backK041701 Afga CR25.0 Computed Radiography SystemAgfa Corp. · 2004
- 2 generations backK062223 Agfa Model CR30-XAgfa Corporation · 2006
- 1 generation backK072010 Quantum Direx SystemQuantum Medical Imaging, LLC · 2007
- This deviceK080905 Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC · 2008
- Descendant · cites it directly · 3 of its ownK193574 Q-Rad SystemCarestream Health, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK201373 DRX-CompassCarestream Health, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 1 of its ownK223842 DRX - CompassCarestream Health, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK250954 DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System…Carestream Health · 2026
Most influential descendants
Showing 4 of 4 · See all- K193574Q-Rad SystemCarestream Health, Inc. · 2020 · cites it directly3descendants
- K201373DRX-CompassCarestream Health, Inc. · 2020 · 2 generations on2descendants
- K223842DRX - CompassCarestream Health, Inc. · 2023 · 3 generations on1descendant
- K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −5 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −4 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −3 | K041701 | Afga CR25.0 Computed Radiography System | Agfa Corp. | 2004 | — |
| −2 | K062223 | Agfa Model CR30-X | Agfa Corporation | 2006 | — |
| −1 | K072010 | Quantum Direx System | Quantum Medical Imaging, LLC | 2007 | — |
| 0 (this device) | K080905 | Quantum/ Canon Cxdi Integration System, Model QG-Dig-Cxdi | Quantum Medical Imaging, LLC | 2008 | — |
| +1 | K193574 | Q-Rad System | Carestream Health, Inc. | 2020 | — |
| +2 | K201373 | DRX-Compass | Carestream Health, Inc. | 2020 | 1 |
| +3 | K223842 | DRX - Compass | Carestream Health, Inc. | 2023 | — |
| +4 | K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35… | Carestream Health | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2023 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K011486 | Q-Rad Radiographic SystemSummary page 1…CXDI-50G Digital Radiography System Manufacturers: Quantum Medical Imaging, LLC / Canon, Inc. Premarket Notifications: K01 1486 / K072010 / K050987 / K031447 Device Description The Quantum / Canon CXDI Integration System consists of add-on software that wi… | 2001 |
| * | K072010 | Quantum Direx SystemSummary page 1…igital Radiography System Manufacturers: Quantum Medical Imaging, LLC / Canon, Inc. Premarket Notifications: K01 1486 / K072010 / K050987 / K031447 Device Description The Quantum / Canon CXDI Integration System consists of add-on software that will allow t… | 2007 |
| * | K050987 | Digital Radiography Model Cxdi-40EGSummary page 1…Radiography System Manufacturers: Quantum Medical Imaging, LLC / Canon, Inc. Premarket Notifications: K01 1486 / K072010 / K050987 / K031447 Device Description The Quantum / Canon CXDI Integration System consists of add-on software that will allow the use of… | 2005 |
| * | K031447 | Canon, Digital Radiography, Model Cxdi-50GSummary page 1…Radiography System Manufacturers: Quantum Medical Imaging, LLC / Canon, Inc. Premarket Notifications: K01 1486 / K072010 / K050987 / K031447 Device Description The Quantum / Canon CXDI Integration System consists of add-on software that will allow the use of the curren… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193574 | Q-Rad System | 2020 | 3 |
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 17 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 20 ancestors have a recall of any class.
- Of its descendants, K193574 (Carestream Health, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K011486.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The Quantum / Canon CXDI Integration System provides diagnostic quality images to aid the physician with diagnosis. The System can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The System is not indicated for use in mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080905: Quantum/ Canon Cxdi Integration System, Model QG-Dig-Cxdi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080905
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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