510(k) · Cleared
Recalled · 2005DR5000 Dedicated Chest X-Ray System
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 Jun 2, 2000 after a 36-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 2, 2000
- Review
- 36 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 2
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK001341 DR5000 Dedicated Chest X-Ray SystemAnalogic Corp. · 2000
- Descendant · cites it directly · 3 of its ownK033345 AN5150 and AN7150 Digital Radiology SystemsAnalogic Corp. · 2003
- Descendant · 2 generations on · 2 of its ownK040995 Synerad Multi Digital X-Ray System, Model AN6150Analogic Corp. · 2004 · Recalled
- Descendant · 3 generations on · 1 of its ownK043025 Synerad Omni, Digital X-Ray System, Model AN6250Analogic Corp. · 2004
- Descendant · 4 generations on · 0 of its ownK071430 Synerad Omni, Models AN6255 and AN6265Analogic Corp. · 2007
Most influential descendants
Showing 4 of 4 · See all- K033345AN5150 and AN7150 Digital Radiology SystemsAnalogic Corp. · 2003 · cites it directly3descendants
- K040995Synerad Multi Digital X-Ray System, Model AN6150Analogic Corp. · 2004 · 2 generations on2descendants
- K043025Synerad Omni, Digital X-Ray System, Model AN6250Analogic Corp. · 2004 · 3 generations on1descendant
- K071430Synerad Omni, Models AN6255 and AN6265Analogic Corp. · 2007 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001341 | DR5000 Dedicated Chest X-Ray System | Analogic Corp. | 2000 | — |
| +1 | K033345 | AN5150 and AN7150 Digital Radiology Systems | Analogic Corp. | 2003 | — |
| +2 | K040995 | Synerad Multi Digital X-Ray System, Model AN6150 | Analogic Corp. | 2004 | 1 |
| +3 | K043025 | Synerad Omni, Digital X-Ray System, Model AN6250 | Analogic Corp. | 2004 | — |
| +4 | K071430 | Synerad Omni, Models AN6255 and AN6265 | Analogic Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033345 | AN5150 and AN7150 Digital Radiology Systems | 2003 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 20, 2005 | Not classified | Z-0274-06 | Other | Potential weld defect in the Overhead Tube Support assembly which connects the tube assembly to the telescoping arm. This could cause the tube assembly to fall, injuring anyone near the unit. |
| Feb 20, 2004 | Not classified | Z-0728-04 | Other | Defective component in overhead tube support balancer may cause the suspended load to fall. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033345 (Analogic Corp., 2003) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K001341 · printed Nov 5, 2026
Cite this page
510(k) Report. “K001341: DR5000 Dedicated Chest X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001341
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026