510(k) · Cleared
ClearedSynerad Omni, Digital X-Ray System, Model AN6250
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Analogic Corp. · KPR System, X-Ray, Stationary
Cleared on Nov 19, 2004 as substantially equivalent to K040995 (Analogic Corp., 2004) after a 16-day review. Its family tree reaches back 5 generations to 1990. 1 later device descends from it.
- Decided
- Nov 19, 2004
- Review
- 16 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K900935 (1990). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK900935 DU Pont Linx Laser Imager W/the Linx NetworkingE.I. Dupont DE Nemours & Co., Inc. · 1990
- 4 generations backK964250 Linx Networking SystemSterling Diagnostic Imaging, Inc. · 1996
- 3 generations backK980970 Iirad Directray Operator ConsoleSterling Diagnostic Imaging, Inc. · 1998
- 2 generations backK033345 AN5150 and AN7150 Digital Radiology SystemsAnalogic Corp. · 2003
- 1 generation backK040995 Synerad Multi Digital X-Ray System, Model AN6150Analogic Corp. · 2004 · Recalled
- This deviceK043025 Synerad Omni, Digital X-Ray System, Model AN6250Analogic Corp. · 2004
- Descendant · cites it directly · 0 of its ownK071430 Synerad Omni, Models AN6255 and AN6265Analogic Corp. · 2007
Most influential descendants
Showing 1 of 1 · See all- K071430Synerad Omni, Models AN6255 and AN6265Analogic Corp. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K900935 | DU Pont Linx Laser Imager W/the Linx Networking | E.I. Dupont DE Nemours & Co., Inc. | 1990 | — |
| −4 | K964250 | Linx Networking System | Sterling Diagnostic Imaging, Inc. | 1996 | — |
| −3 | K980970 | Iirad Directray Operator Console | Sterling Diagnostic Imaging, Inc. | 1998 | — |
| −2 | K033345 | AN5150 and AN7150 Digital Radiology Systems | Analogic Corp. | 2003 | — |
| −1 | K040995 | Synerad Multi Digital X-Ray System, Model AN6150 | Analogic Corp. | 2004 | 1 |
| 0 (this device) | K043025 | Synerad Omni, Digital X-Ray System, Model AN6250 | Analogic Corp. | 2004 | — |
| +1 | K071430 | Synerad Omni, Models AN6255 and AN6265 | Analogic Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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.
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 |
|---|---|---|---|
| * | K040995 | Synerad Multi Digital X-Ray System, Model AN6150Summary page 1…to which equivalence is being claimed is the Analogic AN6150 Digital Radiology System. The predicate system was cleared under Premarket Notification K040995. Analogic Corporation AN6250 Digital Radiology System 510(k) Appendix J-I… | 2004 |
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 |
|---|---|---|---|
| K071430 | Synerad Omni, Models AN6255 and AN6265 | 2007 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K071430 (Analogic Corp., 2007) has gone furthest, with 0 descendants of its own.
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 AN6250 is a digital X-ray general radiography system intended for use by qualified/trained doctor or technician and is designed to perform radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities and other body parts excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or lying in the prone or supine position.
Images from the AN6250 are available for preview by the doctor/X-ray technician on the operator's workstation within seconds of the X-ray exposure. Digital (DICOM) images can be stored on electronic media, or exported to a (DICOM/PACS) network, clinical review station or to a film printer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043025 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043025: Synerad Omni, Digital X-Ray System, Model AN6250.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043025
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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