510(k) · Cleared
ClearedDigiscan FDX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allengers Medical Systems Limited · OWB Interventional Fluoroscopic X-Ray System
Cleared on Jul 13, 2020 as substantially equivalent to K132904 (Ziehm Imaging GmbH, 2013) and 2 other predicates after a 167-day review. Its family tree reaches back 9 generations to 2002. 3 of the 42 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jul 13, 2020
- Review
- 167 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K021049 (2002). 40 ancestors in all, the oldest K860913 (1986). 1 later device descends from it, 1 citing it directly. 3 of the 42 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- 5 generations between
- 3 generations backK170752 OEC EliteOec Medical Systems, Inc. · 2017 · Recalled
- 2 generations backK171565 OEC EliteGe Oec Medical Systems, Inc. · 2017 · Recalled
- 1 generation backK172550 OEC EliteGe Oec Medical Systems, Inc. · 2017 · Recalled
- This deviceK200218 Digiscan FDXAllengers Medical Systems Limited · 2020
- Descendant · cites it directly · 0 of its ownK253296 Digital C-ARM with 3DAllengers Medical Systems Limited · 2026
Show all 9 generations
- Root · 9 generations backK021049 Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · Recalled (Class I)
- 8 generations backK041932 Oec Olympus Fluoroscopic Imaging SystemGe Oec Medical Systems, Inc. · 2004 · Recalled
- 7 generations backK073543 Oec 9900 EliteGe Oec Medical Systems · 2008 · Recalled
- 6 generations backK082781 Oec 9900 EliteGe Healthcare Surgery · 2009 · Recalled
- 5 generations backK120613 Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · Recalled
- 4 generations backK122234 Oec 9900 EliteGe Healthcare Surgery GE Oec Medical Systems, Inc. · 2012 · Recalled
- 3 generations backK170752 OEC EliteOec Medical Systems, Inc. · 2017 · Recalled
- 2 generations backK171565 OEC EliteGe Oec Medical Systems, Inc. · 2017 · Recalled
- 1 generation backK172550 OEC EliteGe Oec Medical Systems, Inc. · 2017 · Recalled
- This deviceK200218 Digiscan FDXAllengers Medical Systems Limited · 2020
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K253296Digital C-ARM with 3DAllengers Medical Systems Limited · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K021049 | Oec 9800 Plus Digital Mobile Imaging System | Ge Oec Medical Systems | 2002 | Class I |
| −8 | K041932 | Oec Olympus Fluoroscopic Imaging System | Ge Oec Medical Systems, Inc. | 2004 | 7 |
| −7 | K073543 | Oec 9900 Elite | Ge Oec Medical Systems | 2008 | 5 |
| −6 | K082781 | Oec 9900 Elite | Ge Healthcare Surgery | 2009 | 4 |
| −5 | K120613 | Oec 9900 Elite | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012 | 7 |
| −4 | K122234 | Oec 9900 Elite | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | 2012 | 6 |
| −3 | K170752 | OEC Elite | Oec Medical Systems, Inc. | 2017 | 4 |
| −2 | K171565 | OEC Elite | Ge Oec Medical Systems, Inc. | 2017 | 4 |
| −1 | K172550 | OEC Elite | Ge Oec Medical Systems, Inc. | 2017 | 4 |
| 0 (this device) | K200218 | Digiscan FDX | Allengers Medical Systems Limited | 2020 | — |
| +1 | 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 |
| 1991 | 4 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 1 |
| 2003 | 2 | 1 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.2 · 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? (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 |
|---|---|---|---|
| * | K132904 | Ziehm Vision RFDSummary page 5…t Code: OWB, JAA, OXO 3. Predicate Device: Device (trade) name: Ziehim Vision RFD 510(K) Number : K132904 Clearance Date : December 05, 2013 Classification Name: Image-Intensifi… | 2013 |
| * | K172550 | OEC EliteSummary page 5…OWB, JAA, OXO 4. Reference devices: Reference Device Device (trade) name: OEC Elite 510(K) Number : K172550 Clearance Date : November 16, 2017 Classification Name: Image-Intensifi… | 2017 |
| * | K153244 | Cios FusionSummary page 6…6 === Allengers Medical Systems Limited Reference Device Device (trade) name: Cios Fusion 510(K) Number : K153244 Clearance Date : March 7, 2016 Classification Name: Image-Intensified F… | 2016 |
| † | K100102 | CS-Series-FP | 2010 |
| † | K113548 | Pedcat | 2012 |
| † | K171755 | CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System | 2018 |
| † | K183040 | Zenition 70 | 2018 |
| † | K172822 | Azurion series R1.2 | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253296 | Digital C-ARM with 3D | 2026 | 0 |
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 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K021049Oec 9800 Plus Digital Mobile Imaging SystemGe Oec Medical Systems · 2002 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K003837Flexiview 8800 Digital Mobile Imaging SystemGe Oec Medical Systems · 2001 · 6 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 30 of the 40 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K253296 (Allengers Medical Systems Limited, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K132904.
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 Digiscan FDX Family, a Mobile C-Arm X-Ray System, is intended to provide Fluoroscopic images of the patient during diagnostic, surgical procedures.
Clinical applications may include (but not limited to) orthopedic, Fertility studies (HSG), GI procedures like endoscopy , neurology, urology, critical care and emergency room procedures.
Digiscan FDX C-Arm is indicated for visualization in real time and/or recording of surgical region of interest and anatomy, using X-Ray imaging technique.
Exclusion: Digiscan FDX Family is not recommended for Mammography.
Contraindications: Exposure of X-Ray should be avoided during pregnancy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200218: Digiscan FDX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200218
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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