510(k) · Cleared
ClearedDRX - Compass
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Health, Inc. · KPR System, X-Ray, Stationary
Cleared on Jan 20, 2023 as substantially equivalent to K201373 (Carestream Health, Inc., 2020) after a 29-day review. Its family tree reaches back 9 generations to 1991. 1 later device descends from it.
- Decided
- Jan 20, 2023
- Review
- 29 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K904519 (1991). 23 ancestors in all, the oldest K803130 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 5 generations between
- 3 generations backK080905 Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC · 2008
- 2 generations backK193574 Q-Rad SystemCarestream Health, Inc. · 2020
- 1 generation backK201373 DRX-CompassCarestream Health, Inc. · 2020 · Recalled
- This deviceK223842 DRX - CompassCarestream Health, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK250954 DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System…Carestream Health · 2026
Show all 9 generations
- Root · 9 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 8 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 7 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 6 generations backK041701 Afga CR25.0 Computed Radiography SystemAgfa Corp. · 2004
- 5 generations backK062223 Agfa Model CR30-XAgfa Corporation · 2006
- 4 generations backK072010 Quantum Direx SystemQuantum Medical Imaging, LLC · 2007
- 3 generations backK080905 Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC · 2008
- 2 generations backK193574 Q-Rad SystemCarestream Health, Inc. · 2020
- 1 generation backK201373 DRX-CompassCarestream Health, Inc. · 2020 · Recalled
- This deviceK223842 DRX - CompassCarestream Health, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector…Carestream Health · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −8 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −7 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −6 | K041701 | Afga CR25.0 Computed Radiography System | Agfa Corp. | 2004 | — |
| −5 | K062223 | Agfa Model CR30-X | Agfa Corporation | 2006 | — |
| −4 | K072010 | Quantum Direx System | Quantum Medical Imaging, LLC | 2007 | — |
| −3 | K080905 | Quantum/ Canon Cxdi Integration System, Model QG-Dig-Cxdi | Quantum Medical Imaging, LLC | 2008 | — |
| −2 | K193574 | Q-Rad System | Carestream Health, Inc. | 2020 | — |
| −1 | K201373 | DRX-Compass | Carestream Health, Inc. | 2020 | 1 |
| 0 (this device) | K223842 | DRX - Compass | Carestream Health, Inc. | 2023 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K201373 | DRX-CompassSummary page 4…585-489-7627 Date Summary Prepared: December 9, 2022 Predicate 510(k) Submitter: Carestream Health, Inc. 510(k) Number: K201373 Trade Name: DRX-Compass Device: System, X-Ray, Stationary Regulation Description: Stationary x-ray system… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector… | 2026 | 0 |
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 32 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 6 of the 23 ancestors have a recall of any class.
- Of its descendants, K250954 (Carestream Health, 2026) has gone furthest, with 0 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. 2023, 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 device is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis.
The system can be used to perform radiographic imaging of various portions of the human body, including the skull,
spinal column, extremities, chest, abdomen and other body parts. The device is not indicated for use in mammography
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223842: DRX - Compass.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223842
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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