510(k) · Cleared
ClearedPanorad, Panorad SL
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 Jan 25, 2012 as substantially equivalent to K101435 (Imix Adr Finland OY, 2010) and 4 other predicates after a 27-day review. Its family tree reaches back 8 generations to 1998.
- Decided
- Jan 25, 2012
- Review
- 27 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 8 generations to K981556 (1998). 47 ancestors in all, the oldest K803130 (1981). No later device cites it as a predicate yet.
- Root · 8 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 7 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 6 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 5 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 4 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 3 generations backK071193 Vidar Vision 3000 and 4000 X-Ray SystemsVidar Systems Corp. · 2007
- 2 generations backK073114 Imix Insight X-Ray SystemsImix Adr Finland OY · 2008
- 1 generation backK101435 Imix Panorad and SomaradImix Adr Finland OY · 2010
- This deviceK113855 Panorad, Panorad SLImix Adr Finland OY · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −7 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −6 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −5 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −4 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −3 | K071193 | Vidar Vision 3000 and 4000 X-Ray Systems | Vidar Systems Corp. | 2007 | — |
| −2 | K073114 | Imix Insight X-Ray Systems | Imix Adr Finland OY | 2008 | — |
| −1 | K101435 | Imix Panorad and Somarad | Imix Adr Finland OY | 2010 | — |
| 0 (this device) | 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 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K101435 | Imix Panorad and SomaradSummary page 1…LLZ Common/Usual Name: General purpose diagnostic X-ray Units with Digital X-ray receptor panels. 2. Equivalent legally marketed devices: IMIX PanoRad (K101435); This modified system employs the DRTech FLAATZ 560 (Ki 11583), OR the DRTech FLAATZ 750E (K080064) OR Konica Minolt… | 2010 |
| * | K111583 | Flaatz 560Summary page 1…50 or 65 kW ORTech FLAATZ 560 (K070618) An -OR- (K111583) or tmage Acquisition Stadler Elektronik FLAATZ 750E (K080064) worksta… | 2011 |
| * | K080064 | Flaatz 750Summary page 1…nels. 2. Equivalent legally marketed devices: IMIX PanoRad (K101435); This modified system employs the DRTech FLAATZ 560 (Ki 11583), OR the DRTech FLAATZ 750E (K080064) OR Konica Minolta AERO DR (K102349) AND K070618, DICOM Pacs made by O&R.. 3. Indications for Use (intended use) PanoRa… | 2008 |
| * | K102349 | Aerodr SystemSummary page 1…evices: IMIX PanoRad (K101435); This modified system employs the DRTech FLAATZ 560 (Ki 11583), OR the DRTech FLAATZ 750E (K080064) OR Konica Minolta AERO DR (K102349) AND K070618, DICOM Pacs made by O&R.. 3. Indications for Use (intended use) PanoRad and PanoRad SL X-Ray Systems are indicat… | 2010 |
| * | K070618 | Dicompacs, Model 5Summary page 1…PanoRad (K101435); This modified system employs the DRTech FLAATZ 560 (Ki 11583), OR the DRTech FLAATZ 750E (K080064) OR Konica Minolta AERO DR (K102349) AND K070618, DICOM Pacs made by O&R.. 3. Indications for Use (intended use) PanoRad and PanoRad SL X-Ray Systems are indicated for… | 2007 |
| † | K073114 | Imix Insight X-Ray Systems | 2008 |
| † | K091364 | Dicompacs, Model 5.2, Dicompacs DX-R, Model 1.4 | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 companies; a new generation was cleared every 1.5 years on median.
- 14 of the 47 ancestors have a recall of any class.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
IMIX PanoRad and PanoRad SL X-Ray Systems are indicated for use in generating radiographic images of human anatomy. They have Solid State X-ray Imaging systems 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/K113855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113855: Panorad, Panorad SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113855
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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