510(k) · Cleared
Cleared3DSCOPE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Direx Systems Corp. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Jul 22, 2004 as substantially equivalent to K965013 (Medirex, Inc., 1997) after a 73-day review. Its family tree reaches back 1 generation to 1997. 9 later devices descend from it.
- Decided
- Jul 22, 2004
- Review
- 73 days
- Class
- Class II
- Product code
- OXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K965013 (1997). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK965013 Digiscope RX-2 (9 Option)Medirex, Inc. · 1997
- This deviceK041213 3DSCOPEDirex Systems Corp. · 2004
- Descendant · cites it directly · 6 of its ownK053640 IntegraDirex Systems Corp. · 2006
- Descendant · 2 generations on · 3 of its ownK062147 Integra SLDirex Systems Corp. · 2006
- Descendant · 2 generations on · 2 of its ownK072538 Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc. · 2008
- Descendant · 3 generations on · 1 of its ownK252913 Break WaveSonomotion, Inc. · 2026
- Descendant · cites it directly · 1 of its ownK052212 MIGUEDirex Systems Corp. · 2006
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K053640IntegraDirex Systems Corp. · 2006 · cites it directly6descendants
- K062147Integra SLDirex Systems Corp. · 2006 · 2 generations on3descendants
- K072538Piezolith 3000 Triple-Focus LithotripterUnited Medical Systems, Inc. · 2008 · 2 generations on2descendants
- K252913Break WaveSonomotion, Inc. · 2026 · 3 generations on1descendant
- K052212MIGUEDirex Systems Corp. · 2006 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K965013 | Digiscope RX-2 (9 Option) | Medirex, Inc. | 1997 | — |
| 0 (this device) | K041213 | 3DSCOPE | Direx Systems Corp. | 2004 | — |
| +1 | K053640 | Integra | Direx Systems Corp. | 2006 | — |
| +2 | K062147 | Integra SL | Direx Systems Corp. | 2006 | — |
| +2 | K072538 | Piezolith 3000 Triple-Focus Lithotripter | United Medical Systems, Inc. | 2008 | — |
| +3 | K252913 | Break Wave | Sonomotion, Inc. | 2026 | — |
| +1 | K052212 | MIGUE | Direx Systems Corp. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 5 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2026 | 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.
Planning a device in OXO? 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 OXO device
- #1 K253296 Digital C-ARM with 3Dscore 15.1 · 13 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 |
|---|---|---|---|
| * | K965013 | Digiscope RX-2 (9 Option) Our OCR of the scanned summary read K865013, FDA’s number for Astra T2, T4 and T6 (Cardiac Pacemakers, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Digiscope RX-2 (9" option)”. | 1997 |
What descends from it? (9)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K053640 (Direx Systems Corp., 2006) has gone furthest, with 6 descendants of its own.
How does its category compare?
All OXO devicesOXO Image-Intensified Fluoroscopic X-Ray System, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OXO
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXO
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OXO
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OXO
118in 2025
MAUDE reports naming product code OXO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 48 | 4 | 5 |
| 2013 | 2 | — | 3 | 41 |
| 2014 | 2 | — | 4 | 89 |
| 2015 | 1 | — | 0 | 97 |
| 2016 | 3 | 128 | 3 | 3,820 |
| 2017 | 4 | 57 | 4 | 1,697 |
| 2018 | 1 | — | 11 | 1,647 |
| 2019 | 3 | 213 | 0 | 1,297 |
| 2020 | 0 | — | 0 | 816 |
| 2021 | 2 | — | 0 | 554 |
| 2022 | 0 | — | 0 | 295 |
| 2023 | 0 | — | 0 | 275 |
| 2024 | 2 | — | 4 | 192 |
| 2025 | 4 | 97 | 0 | 118 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The 3Dscope is a mobile apparatus used for flucroscopic examination of a patient.
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/K041213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041213: 3DSCOPE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041213
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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