510(k) · Cleared
ClearedImix Panorad and Somarad
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imix Adr Finland OY · KPR System, X-Ray, Stationary
Cleared on Sep 15, 2010 as substantially equivalent to K073114 (Imix Adr Finland OY, 2008) and 2 other predicates after a 117-day review. Its family tree reaches back 7 generations to 1998. 1 later device descends from it.
- Decided
- Sep 15, 2010
- Review
- 117 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K981556 (1998). 38 ancestors in all, the oldest K803130 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 6 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 5 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 4 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 3 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 2 generations backK071193 Vidar Vision 3000 and 4000 X-Ray SystemsVidar Systems Corp. · 2007
- 1 generation backK073114 Imix Insight X-Ray SystemsImix Adr Finland OY · 2008
- This deviceK101435 Imix Panorad and SomaradImix Adr Finland OY · 2010
- Descendant · cites it directly · 0 of its ownK113855 Panorad, Panorad SLImix Adr Finland OY · 2012
Most influential descendants
Showing 1 of 1 · See all- K113855Panorad, Panorad SLImix Adr Finland OY · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −6 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −5 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −4 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −3 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −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 | — |
| 0 (this device) | K101435 | Imix Panorad and Somarad | Imix Adr Finland OY | 2010 | — |
| +1 | K113855 | Panorad, Panorad SL | Imix Adr Finland OY | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (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 |
|---|---|---|---|
| * | K073114 | Imix Insight X-Ray SystemsSummary page 1…nary X-ray system, Product Codes Product Codes KPR, MQB, and LLZ Common/Usual Name: General purpose diagnostic X-ray Unit. 2. Equivalent legally marketed devices: K073 114, IMIX Insight; K083645 Radstar Digital Imaging System made by 5-Star, and K07061IS, DICOM Pacs made by O&R. The IMIX PanoRad a… | 2008 |
| * | K083645 | Radstar Family, Models: Radstar 4343 & VariationsSummary page 1…oduct Codes Product Codes KPR, MQB, and LLZ Common/Usual Name: General purpose diagnostic X-ray Unit. 2. Equivalent legally marketed devices: K073 114, IMIX Insight; K083645 Radstar Digital Imaging System made by 5-Star, and K07061IS, DICOM Pacs made by O&R. The IMIX PanoRad and SomnaRad X-Ray Sy… | 2009 |
| * | K070618 | Dicompacs, Model 5Summary page 1…made by 5-Star, and K07061IS, DICOM Pacs made by O&R. The IMIX PanoRad and SomnaRad X-Ray Systems use the identical panel to K083645 and the identical software to K0706 18. 3. Indications for Use (intended use) IMIX PanoRad and SomaRad X-Ray Systems are indicated for use in generating radiographi… | 2007 |
| † | K974863 | Imix Digital Thorax System | 1998 |
| † | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 | 2009 |
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 |
|---|---|---|---|
| K113855 | Panorad, Panorad SL | 2012 | 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 12 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 13 of the 38 ancestors have a recall of any class.
- Of its descendants, K113855 (Imix Adr Finland OY, 2012) 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. 2010, 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?
IMYIX PanoRad and SomnaRad X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (Not for mammography.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101435: Imix Panorad and Somarad.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101435
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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