510(k) · Cleared
ClearedMedicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicatech USA · KPR System, X-Ray, Stationary
Cleared on May 15, 2008 as substantially equivalent to K062335 (Sedecal., Sa., 2006) and 2 other predicates after a 73-day review. Its family tree reaches back 5 generations to 1998. 16 later devices descend from it.
- Decided
- May 15, 2008
- Review
- 73 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K981556 (1998). 11 ancestors in all. 16 later devices descend from it, 2 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 deviceK080582 Medicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FAMedicatech USA · 2008
- Descendant · cites it directly · 14 of its ownK112132 Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA · 2011
- Descendant · 2 generations on · 11 of its ownK130883 Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa. · 2013
- Descendant · 3 generations on · 7 of its ownK140825 Delworks DR SystemDel Medical, 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 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K112132Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA · 2011 · cites it directly14descendants
- K130883Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa. · 2013 · 2 generations on11descendants
- K140825Delworks DR SystemDel Medical, 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) | K080582 | Medicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FA | Medicatech USA | 2008 | — |
| +1 | K112132 | Krystalrad 660 Digital Radiographic Portable Retrofit System | Medicatech USA | 2011 | — |
| +2 | K130883 | Sedecal Digital Radiographic Upgrade Model Sdru-T | Sedecal., Sa. | 2013 | — |
| +3 | K140825 | Delworks DR System | Del Medical, 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 |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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? (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…ted devices: This notification is for a MODIFIED device. This device COMBINES two 510(k) cleared devices, the SEDECAL X PLUS LP PLUS Universal Radiographic Systems K062335 AND a version of the DRtech Digital Panel, K080064. This combination is functionally identical to a SEDECAL cleared device, Se… | 2006 |
| * | K080064 | Flaatz 750Summary page 1…vice. This device COMBINES two 510(k) cleared devices, the SEDECAL X PLUS LP PLUS Universal Radiographic Systems K062335 AND a version of the DRtech Digital Panel, K080064. This combination is functionally identical to a SEDECAL cleared device, Sedecal URS LP X-Ray Units with Digital Detector,… | 2008 |
| * | K042876 | Urs LP Digital, Millennium, RadproSummary page 1…ion of the DRtech Digital Panel, K080064. This combination is functionally identical to a SEDECAL cleared device, Sedecal URS LP X-Ray Units with Digital Detector, K042876.. 3. Indications for Use (intended use) DDR Digital X-Ray Systems are intended for use by a qualified/trained doctor or techn… | 2004 |
What descends from it? (16)
See all 162 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K112132 (Medicatech USA, 2011) has gone furthest, with 14 descendants of its own.
- 4 other devices also cite its predicate K062335.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 DDR Digital X-Ray Systems are 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 as stated in the FDA summary.
https://510kreport.com/device/K080582 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080582: Medicatech, Model DDR Mak-800, DDT Mak-1000 FS, DDR Mak-1100 FA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080582
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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