510(k) · Cleared
ClearedDigital C-ARM with 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allengers Medical Systems Limited · OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Cleared on Jun 5, 2026 as substantially equivalent to K200218 (Allengers Medical Systems Limited, 2020) and 2 other predicates after a 249-day review. Its family tree reaches back 13 generations to 1980. 3 of the 103 devices in its family, counting itself, have a Class I recall.
- Decided
- Jun 5, 2026
- Review
- 249 days
- Class
- Class II
- Product code
- OXO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K801623 (1980). 102 ancestors in all. No later device cites it as a predicate yet. 3 of the 103 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 9 generations between
- 3 generations backK181560 Cios AlphaSiemens Medical Systems USA, Inc. · 2018 · Recalled
- 2 generations backK203504 Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- 1 generation backK210054 Cios SpinSiemens Medical Systems USA, Inc. · 2021 · Recalled
- This deviceK253296 Digital C-ARM with 3DAllengers Medical Systems Limited · 2026
Show all 13 generations
- Root · 13 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 12 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 11 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 10 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 9 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 8 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 7 generations backK073290 Artis Zee and ZeegoSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 6 generations backK090745 Artis Zee / Zeegos with SW VC14Siemens Medical Solutions USA, Inc. · 2009 · Recalled
- 5 generations backK123529 Artis Q and Q.Zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2013 · Recalled
- 4 generations backK163286 ARTIS phenoSiemens Medical Solution USA, Inc. · 2017 · Recalled
- 3 generations backK181560 Cios AlphaSiemens Medical Systems USA, Inc. · 2018 · Recalled
- 2 generations backK203504 Cios FlowSiemens Medical Solutions USA, Inc. · 2020 · Recalled
- 1 generation backK210054 Cios SpinSiemens Medical Systems USA, Inc. · 2021 · Recalled
- This deviceK253296 Digital C-ARM with 3DAllengers Medical Systems Limited · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −12 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −11 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −10 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −9 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −8 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −7 | K073290 | Artis Zee and Zeego | Siemens Medical Solutions USA, Inc. | 2008 | 39 |
| −6 | K090745 | Artis Zee / Zeegos with SW VC14 | Siemens Medical Solutions USA, Inc. | 2009 | 7 |
| −5 | K123529 | Artis Q and Q.Zen- Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2013 | 31 |
| −4 | K163286 | ARTIS pheno | Siemens Medical Solution USA, Inc. | 2017 | 14 |
| −3 | K181560 | Cios Alpha | Siemens Medical Systems USA, Inc. | 2018 | 7 |
| −2 | K203504 | Cios Flow | Siemens Medical Solutions USA, Inc. | 2020 | 1 |
| −1 | K210054 | Cios Spin | Siemens Medical Systems USA, Inc. | 2021 | 1 |
| 0 (this device) | K253296 | Digital C-ARM with 3D | Allengers Medical Systems Limited | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 7 | 0 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 1 | 0 |
| 1995 | 11 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 4 | 0 |
| 2001 | 5 | 1 |
| 2002 | 5 | 1 |
| 2003 | 2 | 1 |
| 2004 | 9 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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.
3 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 OXO device
- #1 K250587 Orthoscan TAU Mini C-Armscore 15.0 · 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? (3)
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 |
|---|---|---|---|
| * | K200218 | Digiscan FDXSummary page 5…Product Code: OXO, JAA, OWB 3. Predicate Device: Device (trade) name: Digiscan FDX 510(K) Number : K200218 Clearance Date : August 7, 2022 Classification Name: Image-Intensifie… | 2020 |
| * | K210054 | Cios SpinSummary page 5…XO, JAA, OWB 4. Reference Device : Reference Device 1 Device (trade) name: Cios Spin 510(K) Number : K210054 Clearance Date : February 05, 2021 Classification Name: Image-Intensi… | 2021 |
| * | K243303 | Ziehm Vision RFD 3DSummary page 6…gers Medical Systems Limited Reference Device 2 Device (trade) name: Ziehm Vision RFD 3D 510(K) Number : K243303 Clearance Date : January 21, 2025 Classification Name: Image-Intensifie… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 5 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 7 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 46 years and passes through 8 companies; a new generation was cleared every 2.0 years on median.
- 51 of the 102 ancestors have a recall of any class; 3 have a Class I 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. 2026, this device’s year, is highlighted.
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?
Digiscan V30 3D is X-Ray based fluoroscopy equipment. It is intended for use in visualizing complex anatomical structures and procedures such as 3D Reconstruction, endoscopy Studies (ERCP), urology, Gastro, orthopedic, neurology, Fertility studies (HSG), cholangiography, vascular angiography with and without subtraction, critical care and emergency room procedures. This equipment produces real time images of anatomy using x-rays.
Exclusion:
Device is not meant for Mammography.
Contraindications of device:
Exposure of X-ray should be avoided during pregnancy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253296: Digital C-ARM with 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253296
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026