510(k) · Cleared
ClearedSee Factor CT3™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epica International, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Jun 21, 2024 as substantially equivalent to K181407 (Siemens Medical Solution USA, Inc., 2018) after a 267-day review. Its family tree reaches back 11 generations to 1980.
- Decided
- Jun 21, 2024
- Review
- 267 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K801623 (1980). 46 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 7 generations between
- 3 generations backK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 2 generations backK141574 Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- 1 generation backK181407 Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. · 2018 · Recalled
- This deviceK233230 See Factor CT3™Epica International, Inc. · 2024
Show all 11 generations
- Root · 11 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 10 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 9 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 8 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 7 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 6 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 5 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 4 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 3 generations backK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 2 generations backK141574 Artis Zee/Zeego SW VC21Siemens Medical Solutions USA, Inc. · 2014 · Recalled
- 1 generation backK181407 Artis zee/zeego & Artis Q/Q.zenSiemens Medical Solution USA, Inc. · 2018 · Recalled
- This deviceK233230 See Factor CT3™Epica International, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −10 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −9 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −8 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −7 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −6 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −5 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −4 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −3 | K123529 | Artis Q and Q.Zen- Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2013 | 31 |
| −2 | K141574 | Artis Zee/Zeego SW VC21 | Siemens Medical Solutions USA, Inc. | 2014 | 12 |
| −1 | K181407 | Artis zee/zeego & Artis Q/Q.zen | Siemens Medical Solution USA, Inc. | 2018 | 59 |
| 0 (this device) | K233230 | See Factor CT3™ | Epica International, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 10 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
| 2013 | 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 OWB? 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 |
|---|---|---|---|
| * | K181407 | Artis zee/zeego & Artis Q/Q.zenSummary page 4…e: Image-intensified fluoroscopic x-ray system Classification Name: 21 CFR 892.1650 Regulatory Class: 2 Product Code: OWB, JAK Predicate Device: Siemens Artis zeego (K181407) Device Description The See Factor CT3™ consists of a Diagnostic CBCT (Cone Beam Computed Tomography) device that integrates Hi… | 2018 |
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?
- The line of descent spans 44 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 12 of the 46 ancestors have a recall of any class.
- 5 other devices also cite its predicate K181407.
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. 2024, 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 See Factor CT3™ is a flat panel cone beam computed tomography X-ray imaging system that is indicated for acquiring images of the head, neck, and limbs in all adult patients. It can also acquire portions of the thorax, spine, and pelvic bones with high x-ray attenuation such as bony structures in supine body parts no wider than 60cm. The device has a 62.5cm gantry bore with a 30cm field of view that can provide 2D and 3D images for all of the stated…
Read the full statement (128 words)
The See Factor CT3™ is a flat panel cone beam computed tomography X-ray imaging system that is indicated for
acquiring images of the head, neck, and limbs in all adult patients. It can also acquire portions of the thorax, spine, and
pelvic bones with high x-ray attenuation such as bony structures in supine body parts no wider than 60cm. The device has
a 62.5cm gantry bore with a 30cm field of view that can provide 2D and 3D images for all of the stated anatomical areas
for both intra-operative and clinical use. The device is also capable of acquiring digital radiography and fluoroscopy
images of the anatomical areas identified above.
The device is to be operated by licensed and credentialed medical professionals such as physicians, and radiology
technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233230 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233230: See Factor CT3™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233230
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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