510(k) · Cleared
ClearedDigiX FDX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Allengers Medical Systems Limited · KPR System, X-Ray, Stationary
Cleared on Mar 3, 2017 as substantially equivalent to K081722 (Siemens Medical Solutions USA, Inc., 2008) and 7 other predicates after a 175-day review. Its family tree reaches back 11 generations to 1980. 6 later devices descend from it.
- Decided
- Mar 3, 2017
- Review
- 175 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 11 generations to K801623 (1980). 112 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 7 generations between
- 3 generations backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 2 generations backK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- 1 generation backK142049 Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014
- This deviceK162529 DigiX FDXAllengers Medical Systems Limited · 2017
- Descendant · cites it directly · 5 of its ownK192541 DigiX FDXAllengers Medical Systems Limited · 2019
- Descendant · 2 generations on · 4 of its ownK223060 DigiX FDXAllengers Medical Systems Limited · 2022
- Descendant · 3 generations on · 3 of its ownK230985 Planmeca VisoPlanmeca Oy · 2023
- Descendant · 4 generations on · 1 of its ownK251842 Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd. · 2025
- Descendant · 5 generations on · 0 of its ownK263033 Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1…Fussen Technology Co., Ltd. · 2026
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 backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 4 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 3 generations backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 2 generations backK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- 1 generation backK142049 Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014
- This deviceK162529 DigiX FDXAllengers Medical Systems Limited · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K192541DigiX FDXAllengers Medical Systems Limited · 2019 · cites it directly5descendants
- K223060DigiX FDXAllengers Medical Systems Limited · 2022 · 2 generations on4descendants
- K230985Planmeca VisoPlanmeca Oy · 2023 · 3 generations on3descendants
- K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd. · 2025 · 4 generations on1descendant
- K263033Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000…Fussen Technology Co., Ltd. · 2026 · 5 generations on0descendants
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 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −4 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| −3 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| −2 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
| −1 | K142049 | Multix Fusion VA30 & VA40 | Siemens Medical Solutions USA, Inc. | 2014 | — |
| 0 (this device) | K162529 | DigiX FDX | Allengers Medical Systems Limited | 2017 | — |
| +1 | K192541 | DigiX FDX | Allengers Medical Systems Limited | 2019 | — |
| +2 | K223060 | DigiX FDX | Allengers Medical Systems Limited | 2022 | — |
| +3 | K230985 | Planmeca Viso | Planmeca Oy | 2023 | — |
| +4 | K251842 | Dental Computed Tomography X-ray System | Fussen Technology Co., Ltd. | 2025 | — |
| +5 | K263033 | Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3)… | Fussen Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 13 | 0 |
| 1996 | 6 | 0 |
| 1997 | 5 | 0 |
| 1998 | 4 | 0 |
| 1999 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2002 | 9 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 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? (8)
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 |
|---|---|---|---|
| * | K081722 | YSIOSummary page 4…assification Panel: Radiology Device Class: Class II Product Code: 90 KPR Predicate device: Predicate device: Siemens Ysio, (K081722) Classification: 21 CFR 892.1680 Classification Name: Stationary x-ray system Common/u… | 2008 |
| * | K130318 | Nexus DRF Digital X-Ray Imaging System (with Paxscan 4343CB)Summary page 5…-1 Section 5-0 Allengers Medical Systems Limited Solid State Detectors Varian PaxScan 4343R – Fixed K130318 Varian PaxScan 4336R – Fixed K130318 Perkin Elmer XRPAD 4343F - Fixed… | 2013 |
| * | K142698 | PerkinElmer, XRpad 4343 F MED Flat Panel DetectorSummary page 5…Fixed K130318 Varian PaxScan 4336R – Fixed K130318 Perkin Elmer XRPAD 4343F - Fixed K142698 Varian PaxScan 4336W – Wireless K142049 Perkin Elmer XRPAD 4336 – Wireless… | 2014 |
| * | K142049 | Multix Fusion VA30 & VA40Summary page 5…Fixed K130318 Perkin Elmer XRPAD 4343F - Fixed K142698 Varian PaxScan 4336W – Wireless K142049 Perkin Elmer XRPAD 4336 – Wireless K140551 Image Processing Software e-COM Technology Ltd.… | 2014 |
| * | K140551 | Perkinelmer, Xrpad 4336 Med Flat Panel DetectorSummary page 5…F - Fixed K142698 Varian PaxScan 4336W – Wireless K142049 Perkin Elmer XRPAD 4336 – Wireless K140551 Image Processing Software e-COM Technology Ltd. DROC K130883 (Digital Radiography O… | 2014 |
| * | K130883 | Sedecal Digital Radiographic Upgrade Model Sdru-TSummary page 5…K142049 Perkin Elmer XRPAD 4336 – Wireless K140551 Image Processing Software e-COM Technology Ltd. DROC K130883 (Digital Radiography Operator Console) Device description: The DigiX FDX system is a diagnostic x-ray system intended fo… | 2013 |
| * | K093066 | I5 Digital X-Ray Imaging System, Model I5Summary page 11…8. Solid State X-ray Image Detectors Model P-E XRPAD 4343F Trixell Pixium 4600 FDA Cleared Yes, K142698 Yes, K093066 Panel Type Thin Film Transistor, Thin Film Transistor, Same Allengers Medical Systems Limited D… | 2010 |
| * | K140825 | Delworks DR SystemSummary page 13…Features Model DROC DelWorks DR System Secondary Predicate FDA Cleared Yes, K130883 Yes, K140825 Operating Microsoft Windows 7 Microsoft Windows 7 Same System Network… | 2014 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192541 | DigiX FDX | 2019 | 5 |
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 37 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 30 of the 112 ancestors have a recall of any class.
- Of its descendants, K192541 (Allengers Medical Systems Limited, 2019) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K081722.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications. Exposure may be taken with the Patient’s sitting, standing, or…
Read the full statement (120 words)
The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications.
Exposure may be taken with the Patient’s sitting, standing, or in the prone position.
The DigiX FDX System is not meant for mammography.
The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.
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/K162529 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162529: DigiX FDX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162529
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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