510(k) · Cleared
Recalled · Class II · 2023Optima Urs Universal Radiographic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sedecal USA, Inc. · KPR System, X-Ray, Stationary
Cleared on Nov 2, 2001 as substantially equivalent to K001201 (Siemens Medical Solutions USA, Inc., 2000) after an 87-day review. Its family tree reaches back 1 generation to 2000. 158 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 2, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001201 (2000). 158 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK001201 Multix Compact K and Multix L Radiographic X-Ray SystemsSiemens Medical Solutions USA, Inc. · 2000
- This deviceK012546 Optima Urs Universal Radiographic SystemSedecal USA, Inc. · 2001
- Descendant · cites it directly · 138 of its ownK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- Descendant · cites it directly · 99 of its ownK062335 Sedecal X Plus LP PlusSedecal., Sa. · 2006
- Descendant · 2 generations on · 46 of its ownK090238 Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa. · 2009
- Descendant · 2 generations on · 41 of its ownK082604 Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc. · 2008
- Descendant · 3 generations on · 36 of its ownK102123 Vizion DRViztek, Inc. · 2011
Showing 5 of 158 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 158 · See all- K042876Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004 · cites it directly138descendants
- K062335Sedecal X Plus LP PlusSedecal., Sa. · 2006 · cites it directly99descendants
- K090238Sedecal X-Plus LP Plus Digital Diagnostic X-Ray SystemsSedecal., Sa. · 2009 · 2 generations on46descendants
- K082604Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc. · 2008 · 2 generations on41descendants
- K102123Vizion DRViztek, Inc. · 2011 · 3 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001201 | Multix Compact K and Multix L Radiographic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 2000 | — |
| 0 (this device) | K012546 | Optima Urs Universal Radiographic System | Sedecal USA, Inc. | 2001 | — |
| +1 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| +1 | K062335 | Sedecal X Plus LP Plus | Sedecal., Sa. | 2006 | — |
| +2 | K090238 | Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems | Sedecal., Sa. | 2009 | — |
| +2 | K082604 | Viztek DR, Models: DR1000, DR3000, DR4000 | Viztek, Inc. | 2008 | — |
| +3 | K102123 | Vizion DR | Viztek, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 8 | 0 |
| 2009 | 3 | 0 |
| 2010 | 7 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 11 | 0 |
| 2015 | 10 | 0 |
| 2016 | 6 | 0 |
| 2017 | 6 | 0 |
| 2018 | 7 | 0 |
| 2019 | 14 | 0 |
| 2020 | 13 | 0 |
| 2021 | 9 | 0 |
| 2022 | 12 | 0 |
| 2023 | 8 | 0 |
| 2024 | 5 | 0 |
| 2025 | 10 | 0 |
| 2026 | 7 | 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? (1)
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 |
|---|---|---|---|
| * | K001201 | Multix Compact K and Multix L Radiographic X-Ray SystemsSummary page 1…KPR Common/Usual Name: Stationary X-Ray System 2. Equivalent legally marketed devices This product is similar in function to the Siemens Multix Stationary X-Ray System (K001201) 3. Indications for Use (intended use) The “Optima URS" Universal Radiographic System is intended for use by a qualified/trained… | 2000 |
What descends from it? (158)
See all 1587 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042876 | Urs LP Digital, Millennium, Radpro | 2004 | 138 |
| K062335 | Sedecal X Plus LP Plus | 2006 | 99 |
| K141192 | DR 400 | 2014 | 7 |
| K072659 | Rad Vision, Models E and EU | 2007 | 7 |
| K071193 | Vidar Vision 3000 and 4000 X-Ray Systems | 2007 | 4 |
| K082261 | Dxrad Models DX800 or DX808 Digital Diagnostic Radiographic Systems | 2008 | 0 |
| K073650 | Fujifilm Unity Speedsuite, Model CR-IR 371 | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 13, 2023 | Class II | Z-0781-2024 | Equipment maintenance | Some parts have fallen off the equipment resulting in a safety risk to patients and/or users. |
| Sep 24, 2002 | Not classified | Z-0652-03 | Other | Incorrect identification labels and their dertification testing program faialed in noncompliance with U.S. Federal performance standards. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 “Optima URS" Universal Radiographic 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/K012546 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012546: Optima Urs Universal Radiographic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012546
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026