510(k) · Cleared
Recalled · Class II · 2020EOSedge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eos Imaging · KPR System, X-Ray, Stationary
Cleared on Sep 16, 2020 as substantially equivalent to K192079 (Eos Imaging, 2019) after a 26-day review. Its family tree reaches back 9 generations to 1981. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 16, 2020
- Review
- 26 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K803130 (1981). 20 ancestors in all, the oldest K790692 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 5 generations between
- 3 generations backK142773 EOS SystemEos Imaging · 2015
- 2 generations backK152788 EOS SystemEos Imaging · 2015
- 1 generation backK192079 EOSedgeEos Imaging · 2019
- This deviceK202394 EOSedgeEos Imaging · 2020
- Descendant · cites it directly · 0 of its ownK233920 EOSedgeEos Imaging · 2024
Show all 9 generations
- Root · 9 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 8 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 7 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 6 generations backK071546 EOSBiospace Med · 2007 · Recalled
- 5 generations backK120721 EOSEos Imaging · 2012
- 4 generations backK123740 EOSEos Imaging · 2013 · Recalled
- 3 generations backK142773 EOS SystemEos Imaging · 2015
- 2 generations backK152788 EOS SystemEos Imaging · 2015
- 1 generation backK192079 EOSedgeEos Imaging · 2019
- This deviceK202394 EOSedgeEos Imaging · 2020
Most influential descendants
Showing 1 of 1 · See all- K233920EOSedgeEos Imaging · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −8 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −7 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −6 | K071546 | EOS | Biospace Med | 2007 | 1 |
| −5 | K120721 | EOS | Eos Imaging | 2012 | — |
| −4 | K123740 | EOS | Eos Imaging | 2013 | 1 |
| −3 | K142773 | EOS System | Eos Imaging | 2015 | — |
| −2 | K152788 | EOS System | Eos Imaging | 2015 | — |
| −1 | K192079 | EOSedge | Eos Imaging | 2019 | — |
| 0 (this device) | K202394 | EOSedge | Eos Imaging | 2020 | — |
| +1 | K233920 | EOSedge | Eos Imaging | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K192079 | EOSedgeSummary page 4…ulatory Class: Class II Product Code: KPR – System, X-ray, Stationary Predicate Device: EOS imaging’s EOSedge System (K192079) Common or Usual Name: Digital Radiography System Classification Name: 21 C.F.R §892.1680; Stationary X-ra… | 2019 |
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 |
|---|---|---|---|
| K233920 | EOSedge | 2024 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2020 | Class II | Z-1415-2021 | Software design | Inadequate images resizing and 2D measurement errors may occur when biplanar acquisition has been performed with patient orientation different from AP (Antero-Posterior). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 39 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 9 of the 20 ancestors have a recall of any class.
- Of its descendants, K233920 (Eos Imaging, 2024) 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. 2020, 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?
EOSedge is intended for use in general radiographic exams and applications, excluding the evaluation of lung nodules and exams involving fluoroscopy, angiography, and mammography. EOSedge allows the radiographic acquisition of either one or two orthogonal X-ray images, for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient, in the upright or seated position.
The Micro Dose feature is indicated for assessing global skeletal deformities in follow-up pediatric exams.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202394: EOSedge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202394
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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