510(k) · Cleared
ClearedTelevere Podiatry X-Ray System HF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Televere Systems, Inc. · KPR System, X-Ray, Stationary
Cleared on Apr 20, 2018 as substantially equivalent to K160857 (Arquilla, Inc. Dba X-Cel X-Ray Corporation, 2017) and 1 other predicate after a 28-day review. Its family tree reaches back 10 generations to 1998.
- Decided
- Apr 20, 2018
- Review
- 28 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K981556 (1998). 23 ancestors in all, the oldest K811230 (1981). No later device cites it as a predicate yet.
- Root · 10 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 6 generations between
- 3 generations backK112661 Vizion DRViztek, LLC · 2011
- 2 generations backK123644 Vizion + DRViztek, LLC · 2013
- 1 generation backK170975 Televere Digital Imaging SystemTelevere Systems · 2017
- This deviceK180765 Televere Podiatry X-Ray System HFTelevere Systems, Inc. · 2018
Show all 10 generations
- Root · 10 generations backK981556 Canon X-Ray Digital Camera Cxdi-11Canon USA, Inc. · 1998
- 9 generations backK992547 Canon X-Ray Digital Camera, Model Cxdi-22Canon USA, Inc. · 1999
- 8 generations backK023750 Cannon Digital Radiography Model Cxdi-40GCanon USA, Inc. · 2002
- 7 generations backK031447 Canon, Digital Radiography, Model Cxdi-50GCanon, Inc. · 2003
- 6 generations backK042876 Urs LP Digital, Millennium, RadproSedecal., Sa. · 2004
- 5 generations backK082604 Viztek DR, Models: DR1000, DR3000, DR4000Viztek, Inc. · 2008
- 4 generations backK102123 Vizion DRViztek, Inc. · 2011
- 3 generations backK112661 Vizion DRViztek, LLC · 2011
- 2 generations backK123644 Vizion + DRViztek, LLC · 2013
- 1 generation backK170975 Televere Digital Imaging SystemTelevere Systems · 2017
- This deviceK180765 Televere Podiatry X-Ray System HFTelevere Systems, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K981556 | Canon X-Ray Digital Camera Cxdi-11 | Canon USA, Inc. | 1998 | — |
| −9 | K992547 | Canon X-Ray Digital Camera, Model Cxdi-22 | Canon USA, Inc. | 1999 | — |
| −8 | K023750 | Cannon Digital Radiography Model Cxdi-40G | Canon USA, Inc. | 2002 | — |
| −7 | K031447 | Canon, Digital Radiography, Model Cxdi-50G | Canon, Inc. | 2003 | — |
| −6 | K042876 | Urs LP Digital, Millennium, Radpro | Sedecal., Sa. | 2004 | — |
| −5 | K082604 | Viztek DR, Models: DR1000, DR3000, DR4000 | Viztek, Inc. | 2008 | — |
| −4 | K102123 | Vizion DR | Viztek, Inc. | 2011 | — |
| −3 | K112661 | Vizion DR | Viztek, LLC | 2011 | — |
| −2 | K123644 | Vizion + DR | Viztek, LLC | 2013 | — |
| −1 | K170975 | Televere Digital Imaging System | Televere Systems | 2017 | — |
| 0 (this device) | K180765 | Televere Podiatry X-Ray System HF | Televere Systems, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K160857 | HF 718BD X-Ray SystemSummary page 4…: Stationary X-Ray System Device Class/Regulation Number:Class II per regulation 21 C.F.R. §892.1680 2. Equivalent legally marketed device: Model HF 718BD X-Ray System (K160857), X-CEL X-Ray Corp. Classification Name: Stationary X-ray System Product Code: KPR Common/Usual Name: Stationary X-Ray System Dev… | 2017 |
| * | K170975 | Televere Digital Imaging SystemSummary page 6…laboratory testing to applicable standards, it is the conclusion of Televere that the Televere Podiatry X-Ray System HF is as safe and effective as the predicate device K170975, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predica… | 2017 |
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 20 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 23 ancestors has a recall of any class.
- 1 other device also cites its predicate K160857.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The Televere Podiatry X-Ray System HF is intended for use by qualified clinicians for the x-ray of hands and feet. Not for mammography. Not fluoroscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180765 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180765: Televere Podiatry X-Ray System HF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180765
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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