510(k) · Cleared
ClearedORCA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lunar Corp. · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on May 20, 1996 as substantially equivalent to K951765 (Ge Dec Medical Systems, 1995) after a 76-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- May 20, 1996
- Review
- 76 days
- Class
- Class II
- Product code
- OXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951765 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK951765 Series 6600 Digital Mobile C-ArmGe Dec Medical Systems · 1995
- This deviceK960907 ORCALunar Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951765 | Series 6600 Digital Mobile C-Arm | Ge Dec Medical Systems | 1995 | — |
| 0 (this device) | K960907 | ORCA | Lunar Corp. | 1996 | — |
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 |
|---|---|---|---|
| * | K951765 | Series 6600 Digital Mobile C-ArmSummary page 1…ate: February 23, 1996 Device/Trade Name: ORCA Common Name: Ortho C-Arm Qlassification Name: Image Intensified Fluoroscopic X-Ray System 21CFR 892.1650 Predicate Device: K95 1765 OEC Medical Systems Inc. Series 6600 Digital Mobile C-Arm DESCRIPTION OF THE DEVICE: The ORCA is a small image intensified fluor… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
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.
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 ORCA is a small image intensified fluoroscopic C-Arm, for imaging extremities in orthopedic applications. The ORCA Operator’s manual contains the following statement:
“CAUTION: Federal Law (USA) restricts this device to sale and use by or on the order of a physician.”
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/K960907 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960907: ORCA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960907
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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