510(k) · Cleared
ClearedImix Digital Thorax System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Instrument Development, Inc. · KPR System, X-Ray, Stationary
Cleared on Mar 17, 1998 after a 78-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Mar 17, 1998
- Review
- 78 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK974863 Imix Digital Thorax SystemAdvanced Instrument Development, Inc. · 1998
- Descendant · cites it directly · 5 of its ownK070563 Vidar Vision 2000Vidar Systems Corp. · 2007
- Descendant · 2 generations on · 4 of its ownK071193 Vidar Vision 3000 and 4000 X-Ray SystemsVidar Systems Corp. · 2007
- Descendant · cites it directly · 2 of its ownK073114 Imix Insight X-Ray SystemsImix Adr Finland OY · 2008
- Descendant · 2 generations on · 1 of its ownK101435 Imix Panorad and SomaradImix Adr Finland OY · 2010
- Descendant · cites it directly · 1 of its ownK992955 Xplorer 1000Imaging Dynamics Corp. · 2000
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K070563Vidar Vision 2000Vidar Systems Corp. · 2007 · cites it directly5descendants
- K071193Vidar Vision 3000 and 4000 X-Ray SystemsVidar Systems Corp. · 2007 · 2 generations on4descendants
- K073114Imix Insight X-Ray SystemsImix Adr Finland OY · 2008 · cites it directly2descendants
- K101435Imix Panorad and SomaradImix Adr Finland OY · 2010 · 2 generations on1descendant
- K992955Xplorer 1000Imaging Dynamics Corp. · 2000 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974863 | Imix Digital Thorax System | Advanced Instrument Development, Inc. | 1998 | — |
| +1 | K070563 | Vidar Vision 2000 | Vidar Systems Corp. | 2007 | — |
| +2 | K071193 | Vidar Vision 3000 and 4000 X-Ray Systems | Vidar Systems Corp. | 2007 | — |
| +1 | K073114 | Imix Insight X-Ray Systems | Imix Adr Finland OY | 2008 | — |
| +2 | K101435 | Imix Panorad and Somarad | Imix Adr Finland OY | 2010 | — |
| +1 | K992955 | Xplorer 1000 | Imaging Dynamics Corp. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
3 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?
- Of its descendants, K070563 (Vidar Systems Corp., 2007) has gone furthest, with 5 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?
General Radiography as prescribed by competent authority.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974863 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974863: Imix Digital Thorax System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974863
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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