510(k) · Cleared
ClearedQ-Rad Radiographic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantum Medical Imaging, LLC · KPR System, X-Ray, Stationary
Cleared on Jun 20, 2001 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Jun 20, 2001
- Review
- 36 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 5 citing it directly.
- This deviceK011486 Q-Rad Radiographic SystemQuantum Medical Imaging, LLC · 2001
- Descendant · cites it directly · 5 of its ownK072010 Quantum Direx SystemQuantum Medical Imaging, LLC · 2007
- Descendant · cites it directly · 4 of its ownK080905 Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC · 2008
- Descendant · 2 generations on · 3 of its ownK193574 Q-Rad SystemCarestream Health, Inc. · 2020
- Descendant · 3 generations on · 2 of its ownK201373 DRX-CompassCarestream Health, Inc. · 2020 · Recalled
- Descendant · cites it directly · 2 of its ownK073632 Intuition, Model 0170Arcoma AB · 2008
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K072010Quantum Direx SystemQuantum Medical Imaging, LLC · 2007 · cites it directly5descendants
- K080905Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC · 2008 · cites it directly4descendants
- K193574Q-Rad SystemCarestream Health, Inc. · 2020 · 2 generations on3descendants
- K201373DRX-CompassCarestream Health, Inc. · 2020 · 3 generations on2descendants
- K073632Intuition, Model 0170Arcoma AB · 2008 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011486 | Q-Rad Radiographic System | Quantum Medical Imaging, LLC | 2001 | — |
| +1 | K072010 | Quantum Direx System | Quantum Medical Imaging, LLC | 2007 | — |
| +1 | K080905 | Quantum/ Canon Cxdi Integration System, Model QG-Dig-Cxdi | Quantum Medical Imaging, LLC | 2008 | — |
| +2 | K193574 | Q-Rad System | Carestream Health, Inc. | 2020 | — |
| +3 | K201373 | DRX-Compass | Carestream Health, Inc. | 2020 | 1 |
| +1 | K073632 | Intuition, Model 0170 | Arcoma AB | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 3 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 115 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?
- Of its descendants, K072010 (Quantum Medical Imaging, LLC, 2007) has gone furthest, with 5 descendants of its own.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
https://510kreport.com/device/K011486 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011486: Q-Rad Radiographic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011486
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026