510(k) · Cleared
ClearedHF 718BD X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arquilla, Inc. Dba X-Cel X-Ray Corporation · KPR System, X-Ray, Stationary
Cleared on Feb 24, 2017 as substantially equivalent to K811230 (X-Cel X-Ray Corp., 1981) after a 332-day review. Its family tree reaches back 1 generation to 1981. 2 later devices descend from it.
- Decided
- Feb 24, 2017
- Review
- 332 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K811230 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK811230 X-Cell X-Ray #'S P-75W/P-75MX-Cel X-Ray Corp. · 1981
- This deviceK160857 HF 718BD X-Ray SystemArquilla, Inc. Dba X-Cel X-Ray Corporation · 2017
- Descendant · cites it directly · 0 of its ownK231761 PodSKAN HF Diagnostic X-ray SystemSkanray Technologies Limited · 2023
- Descendant · cites it directly · 0 of its ownK180765 Televere Podiatry X-Ray System HFTelevere Systems, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K811230 | X-Cell X-Ray #'S P-75W/P-75M | X-Cel X-Ray Corp. | 1981 | — |
| 0 (this device) | K160857 | HF 718BD X-Ray System | Arquilla, Inc. Dba X-Cel X-Ray Corporation | 2017 | — |
| +1 | K231761 | PodSKAN HF Diagnostic X-ray System | Skanray Technologies Limited | 2023 | — |
| +1 | K180765 | Televere Podiatry X-Ray System HF | Televere Systems, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K811230 | X-Cell X-Ray #'S P-75W/P-75MSummary page 4…ication: Code KPR Legally Marketed X-Cel X-Ray Model 700 Series P-75W/P-75M, manufactured by X- Predicate Device: Cel X-Ray Corporation (K811230) 5.1 Description of the New MODEL HF 718BD X-RAY SYSTEM The new MODEL HF 718BD X-RAY SYSTEM is a stationary x-… | 1981 |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K231761 (Skanray Technologies Limited, 2023) 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. 2017, 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 HF 718BD X-Ray System is intended for use by qualified clinicians for the x-ray of hands and feet.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160857 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160857: HF 718BD X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160857
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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