510(k) · Cleared
Recalled · 2009Definium 5000 X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sedecal., Sa. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Nov 17, 2006 as substantially equivalent to K062335 (Sedecal., Sa., 2006) and 2 other predicates after an 18-day review. Its family tree reaches back 5 generations to 1998. 14 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 17, 2006
- Review
- 18 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 5 generations to K981556 (1998). 12 ancestors in all, the oldest K862120 (1986). 14 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 4 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 3 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 2 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 1 generation backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- This deviceK063283 Definium 5000 X-Ray SystemSedecal., Sa. · 2006
- Descendant · cites it directly · 13 of its ownK122495 Perkinelmer XRD 1622 AP3 Med Flat Panel DetectorPerkinelmer, Inc. · 2012
- Descendant · 2 generations on · 12 of its ownK140551 Perkinelmer, Xrpad 4336 Med Flat Panel DetectorPerkinelmer, Inc. · 2014
- Descendant · 3 generations on · 7 of its ownK142698 PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinelmer, Inc. · 2014
- Descendant · 3 generations on · 6 of its ownK162529 DigiX FDXAllengers Medical Systems Limited · 2017
- Descendant · 4 generations on · 5 of its ownK192541 DigiX FDXAllengers Medical Systems Limited · 2019
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K122495Perkinelmer XRD 1622 AP3 Med Flat Panel DetectorPerkinelmer, Inc. · 2012 · cites it directly13descendants
- K140551Perkinelmer, Xrpad 4336 Med Flat Panel DetectorPerkinelmer, Inc. · 2014 · 2 generations on12descendants
- K142698PerkinElmer, XRpad 4343 F MED Flat Panel DetectorPerkinelmer, Inc. · 2014 · 3 generations on7descendants
- K162529DigiX FDXAllengers Medical Systems Limited · 2017 · 3 generations on6descendants
- K192541DigiX FDXAllengers Medical Systems Limited · 2019 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −4 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −3 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −2 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −1 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| 0 (this device) | K063283 | Definium 5000 X-Ray System | Sedecal., Sa. | 2006 | — |
| +1 | K122495 | Perkinelmer XRD 1622 AP3 Med Flat Panel Detector | Perkinelmer, Inc. | 2012 | — |
| +2 | K140551 | Perkinelmer, Xrpad 4336 Med Flat Panel Detector | Perkinelmer, Inc. | 2014 | — |
| +3 | K142698 | PerkinElmer, XRpad 4343 F MED Flat Panel Detector | Perkinelmer, Inc. | 2014 | — |
| +3 | K162529 | DigiX FDX | Allengers Medical Systems Limited | 2017 | — |
| +4 | K192541 | DigiX FDX | Allengers Medical Systems Limited | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 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 |
|---|---|---|---|
| * | K062335 | Sedecal X Plus LP PlusSummary page 1…marketed devices: This notification is for a MODIFIED device. This device COMBINES two 510(k) cleared devices, the SEDECAL X PLLUS LP PLUS Universal Radiographic Systems K062335 AND the GE Medical Systems Digital Radiographic Detector, K041922. This combination is functionally identical to a SEDECAL. clear… | 2006 |
| * | K041922 | GE Tethered Portable Digital Radiographic DetectorSummary page 1…device COMBINES two 510(k) cleared devices, the SEDECAL X PLLUS LP PLUS Universal Radiographic Systems K062335 AND the GE Medical Systems Digital Radiographic Detector, K041922. This combination is functionally identical to a SEDECAL. cleared device, Sedccal URS LP X-Ray Units with Digital Detector, K0428… | 2004 |
| * | K042876 | Urs LP Digital, Millennium, RadproSummary page 1…ystems Digital Radiographic Detector, K041922. This combination is functionally identical to a SEDECAL. cleared device, Sedccal URS LP X-Ray Units with Digital Detector, K042876. . Indications for Use (intended usc) The Definium™ 5000 X-Ray Systems are intended for use by a qualificd/trained doctor or tec… | 2004 |
| † | K031447 | Canon, Digital Radiography, Model Cxdi-50G | 2003 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122495 | Perkinelmer XRD 1622 AP3 Med Flat Panel Detector | 2012 | 13 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2009 | Not classified | Z-1118-2009 | Radiation Control for Health and Safety Act | A defect in the AEC board in the system's control causes failure to terminate additional exposures at the exposure time selected for the initial exposure. |
| Dec 17, 2007 | Not classified | Z-1133-2008 | Radiation Control for Health and Safety Act | GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue. |
| Dec 17, 2007 | Not classified | Z-1134-2008 | Radiation Control for Health and Safety Act | GE Definium 5000 Collimator failed compliance testing due to a blade sizing issue. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K122495 (Perkinelmer, Inc., 2012) has gone furthest, with 13 descendants of its own.
- 4 other devices also cite its predicate K062335.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
The Definium™ 5000 X-Ray System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
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/K063283 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063283: Definium 5000 X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063283
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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