510(k) · Cleared
ClearedQuantum Direx 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 Aug 7, 2007 as substantially equivalent to K011486 (Quantum Medical Imaging, LLC, 2001) and 4 other predicates after a 15-day review. Its family tree reaches back 5 generations to 1991. 5 later devices descend from it.
- Decided
- Aug 7, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K904519 (1991). 13 ancestors in all, the oldest K803130 (1981). 5 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 4 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 3 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 2 generations backK041701 Afga CR25.0 Computed Radiography SystemAgfa Corp. · 2004
- 1 generation backK062223 Agfa Model CR30-XAgfa Corporation · 2006
- This deviceK072010 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 · 4 generations on · 1 of its ownK223842 DRX - CompassCarestream Health, Inc. · 2023
- Descendant · 5 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 5 of 5 · See all- 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
- K223842DRX - CompassCarestream Health, Inc. · 2023 · 4 generations on1descendant
- K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −4 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −3 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −2 | K041701 | Afga CR25.0 Computed Radiography System | Agfa Corp. | 2004 | — |
| −1 | K062223 | Agfa Model CR30-X | Agfa Corporation | 2006 | — |
| 0 (this device) | 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 |
| +4 | K223842 | DRX - Compass | Carestream Health, Inc. | 2023 | — |
| +5 | 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 |
| 2001 | 2 | 0 |
| 2006 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 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 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? (5)
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…0 Class T Quantum Q-Rad Radiographic System / Agfa DX-S CR System / Agfa DX- Si System / Agfa CR85-X Digitizer / Agfa CR30-X Quantum Medical Imaging, LLC / Agfa Corp. K011486 / K053634 / K063421 / K062742 / K062223 The Quantum DiRex System is an integrated digital imaging system that combines the curre… | 2001 |
| * | K053634 | Computed Radiography System with NX 1.0 WorkstationSummary page 1…Quantum Q-Rad Radiographic System / Agfa DX-S CR System / Agfa DX- Si System / Agfa CR85-X Digitizer / Agfa CR30-X Quantum Medical Imaging, LLC / Agfa Corp. K011486 / K053634 / K063421 / K062742 / K062223 The Quantum DiRex System is an integrated digital imaging system that combines the currently marke… | 2006 |
| * | K063421 | DX-SISummary page 1…-Rad Radiographic System / Agfa DX-S CR System / Agfa DX- Si System / Agfa CR85-X Digitizer / Agfa CR30-X Quantum Medical Imaging, LLC / Agfa Corp. K011486 / K053634 / K063421 / K062742 / K062223 The Quantum DiRex System is an integrated digital imaging system that combines the currently marketed Quantu… | 2006 |
| * | K062742 | CR 85-XSummary page 1…graphic System / Agfa DX-S CR System / Agfa DX- Si System / Agfa CR85-X Digitizer / Agfa CR30-X Quantum Medical Imaging, LLC / Agfa Corp. K011486 / K053634 / K063421 / K062742 / K062223 The Quantum DiRex System is an integrated digital imaging system that combines the currently marketed Quantum Q-Rad Ra… | 2006 |
| * | K062223 | Agfa Model CR30-XSummary page 1…stem / Agfa DX-S CR System / Agfa DX- Si System / Agfa CR85-X Digitizer / Agfa CR30-X Quantum Medical Imaging, LLC / Agfa Corp. K011486 / K053634 / K063421 / K062742 / K062223 The Quantum DiRex System is an integrated digital imaging system that combines the currently marketed Quantum Q-Rad Radiographic… | 2006 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080905 | Quantum/ Canon Cxdi Integration System, Model QG-Dig-Cxdi | 2008 | 4 |
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 16 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K080905 (Quantum Medical Imaging, LLC, 2008) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K011486.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Quantum DiRex System provides diagnostic quality images to aid the physician with diagnosis. The DiRex can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The DiRex is not indicated for use in 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/K072010 · printed Nov 3, 2026
Cite this page
510(k) Report. “K072010: Quantum Direx System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K072010
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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