510(k) · Cleared
ClearedControlRad Trace Model 9
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Controlrad, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Jun 24, 2020 as substantially equivalent to K183109 (Controlrad, Inc., 2019) after a 103-day review. Its family tree reaches back 7 generations to 2002. 2 of the 12 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Jun 24, 2020
- Review
- 103 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K021049 (2002). 8 ancestors in all. 3 later devices descend from it, 2 citing it directly. 2 of the 12 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- 6 generations backK041932 Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 2004 · Recalled
- 5 generations backK073543 Oec 9900 EliteGe Oec Medical Systems · 2008 · Recalled
- 4 generations backK082781 Oec 9900 EliteGe Healthcare Surgery · 2009 · Recalled
- 3 generations backK111551 Oec (R) 9800, Oec (R) 9800 PlusGe Oec Medical Systems, Inc. · 2011 · Recalled
- 2 generations backK132027 Oec 9800 PlusGe Oec Medical Systems, Inc. · 2014 · Recalled
- 1 generation backK183109 ControlRad Trace Model 8Controlrad, Inc. · 2019
- This deviceK200663 ControlRad Trace Model 9Controlrad, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK202431 ControlRad Select Model ZControlrad, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK213455 ControlRad Select Model ZControlrad, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK211782 ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad…Controlrad, Inc. · 2021
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K202431ControlRad Select Model ZControlrad, Inc. · 2020 · cites it directly2descendants
- K213455ControlRad Select Model ZControlrad, Inc. · 2021 · 2 generations on0descendants
- K211782ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9Controlrad, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K021049 | Oec 9800 Plus Digital Mobile Imaging System | Ge Oec Medical Systems | 2002 | Class I |
| −6 | K041932 | Oec Olympus Fluoroscopic Imaging System | Ge Oec Medical Systems, Inc. | 2004 | 7 |
| −5 | K073543 | Oec 9900 Elite | Ge Oec Medical Systems | 2008 | 5 |
| −4 | K082781 | Oec 9900 Elite | Ge Healthcare Surgery | 2009 | 4 |
| −3 | K111551 | Oec (R) 9800, Oec (R) 9800 Plus | Ge Oec Medical Systems, Inc. | 2011 | 9 |
| −2 | K132027 | Oec 9800 Plus | Ge Oec Medical Systems, Inc. | 2014 | 8 |
| −1 | K183109 | ControlRad Trace Model 8 | Controlrad, Inc. | 2019 | — |
| 0 (this device) | K200663 | ControlRad Trace Model 9 | Controlrad, Inc. | 2020 | — |
| +1 | K202431 | ControlRad Select Model Z | Controlrad, Inc. | 2020 | — |
| +2 | K213455 | ControlRad Select Model Z | Controlrad, Inc. | 2021 | — |
| +1 | K211782 | ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 | Controlrad, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 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.
2 devices in this family have a Class I recall. 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K183109 | ControlRad Trace Model 8Summary page 4…Radiology Product Code(s) Primary: OWB Secondary: OXO, JAA Predicate Device: Device Name ControlRad™ Trace Model 8 (K183109) Common Name Interventional Fluoroscopic X-ray System Regulation 21 CFR §892.1650 Classification Name… | 2019 |
| † | K122234 | Oec 9900 Elite | 2012 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K024012Oec 9800 E/CV+ Digital Mobile Imaging SystemGe Oec Medical Systems · 2003 · 6 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 6 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 7 of the 8 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K202431 (Controlrad, Inc., 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K183109.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The ControlRadTM Trace Model 9, when used with OEC® 9900 Elite, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace’s region of interest (ROI) as compared to OEC® 9900 Elite non-collimated image area.1 The ControlRad Trace semi-transparent filter should not be used…
Read the full statement (163 words)
The ControlRadTM Trace Model 9, when used with OEC® 9900 Elite, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace’s region of interest (ROI) as compared to OEC® 9900 Elite non-collimated image area.1 The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9900 Elite’s collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
1 Relative to open Field of View (FOV), the ControlRad Trace Model 9 reduces at least 50% of the Dose Area Product at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200663 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200663: ControlRad Trace Model 9.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200663
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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